Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar2Product Code
- JTNSusceptibility Test Discs, Antimicrobial2Product Code
- JTTSusceptibility Test Powders, Antimicrobial2Product Code
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth2Product Code
- JWYManual Antimicrobial Susceptibility Test Systems2Product Code
- K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)2Cleared 510(K)
- K242658The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL2Cleared 510(K)
- K243201The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL2Cleared 510(K)
- K242905The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL2Cleared 510(K)
- K243202MTS Ceftobiprole 0.002-32 µg/mL2Cleared 510(K)
- K243169The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL2Cleared 510(K)
- K242653The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL2Cleared 510(K)
- K242657The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL2Cleared 510(K)
- K242021The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.2Cleared 510(K)
- K241967The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.2Cleared 510(K)
- K240445The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.2Cleared 510(K)
- K232310Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml2Cleared 510(K)
- K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD2Cleared 510(K)
- K231988Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml2Cleared 510(K)
- K231994Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL2Cleared 510(K)
- K230935Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)2Cleared 510(K)
- K230479ComASP Cefiderocol 0.008-1282Cleared 510(K)
- K223844Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)2Cleared 510(K)
- K203741Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml2Cleared 510(K)
- K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)2Cleared 510(K)
- K211672MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL2Cleared 510(K)
- K202612Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)2Cleared 510(K)
- K202423MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)2Cleared 510(K)
- K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)2Cleared 510(K)
- K200308MTS Lefamulin 0.016- 256 µg/mL2Cleared 510(K)
- K200180MTS Omadacycline 0.002 - 32 ug/mL2Cleared 510(K)
- K193538Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml2Cleared 510(K)
- K193024Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL2Cleared 510(K)
- K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)2Cleared 510(K)
- K192355MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)2Cleared 510(K)
- K192729Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml2Cleared 510(K)
- K192345MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL2Cleared 510(K)
- K192250Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL2Cleared 510(K)
- K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)2Cleared 510(K)
- K191908MTS Imipenem 0.016-256 µg/mL2Cleared 510(K)
- K191809MTS Imipenem-relebactam 0.002/4-32/4 µg/mL2Cleared 510(K)
- K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)2Cleared 510(K)
- K190914MTS Doxycycline 0.016 - 256 µg/mL2Cleared 510(K)
- K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)2Cleared 510(K)
- K190109MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)2Cleared 510(K)
- K190252MTS Gentamicin 0.016 - 256 µg/mL2Cleared 510(K)
- K183527MTS Ciprofloxacin 0.002 - 32 µg/mL2Cleared 510(K)
- K183324Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL2Cleared 510(K)
- K183140MTS Tetracycline 0.016 - 256 ug/mL2Cleared 510(K)
- K183031ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)2Cleared 510(K)
- K183033Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml2Cleared 510(K)
- K183115MTS Levofloxacin 0.002 - 32 µg/mL2Cleared 510(K)
- K182922MTS Omadacycline 0.002-32 µg/mL2Cleared 510(K)
- K182797Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL2Cleared 510(K)
- K182557MTS Eravacycline 0.002 - 32 µg/mL2Cleared 510(K)
- K181889MTS Penicillin 0.002- 32 µg/mL2Cleared 510(K)
- K181946Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL2Cleared 510(K)
- K181708MTS Plazomicin 0.016-256 µg/mL2Cleared 510(K)
- K180936ETEST Telavancin (TLA) (0.002-32 ug/mL)2Cleared 510(K)
- K180886Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL2Cleared 510(K)
- K180339Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL2Cleared 510(K)
- K180330Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL2Cleared 510(K)
- K173817Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL2Cleared 510(K)
- K173307Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL2Cleared 510(K)
- K173209Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL2Cleared 510(K)
- K172542Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.2Cleared 510(K)
- K172454Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL2Cleared 510(K)
- K172109Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL2Cleared 510(K)
- K172150Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)2Cleared 510(K)
- K172274The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL2Cleared 510(K)
- K171906Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL2Cleared 510(K)
- K171870The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL2Cleared 510(K)
- K170772Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL2Cleared 510(K)
- K170670Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)2Cleared 510(K)
- K170892Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL2Cleared 510(K)
- K163517Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL2Cleared 510(K)
- K163298Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL2Cleared 510(K)
- K162854Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml2Cleared 510(K)
- K161175Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL2Cleared 510(K)
- K153569Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml2Cleared 510(K)
- K153687Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL2Cleared 510(K)
- K152774The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL2Cleared 510(K)
- K151873Etest Ceftaroline (0.002 - 32ug/ml)2Cleared 510(K)
- K152346MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)2Cleared 510(K)
- K150556Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)2Cleared 510(K)
- K150236Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)2Cleared 510(K)
- K143288Sensititre Susceptibility plates2Cleared 510(K)
- K143526The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)2Cleared 510(K)
- K142338Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)2Cleared 510(K)
- K143381Sensititre Susceptibility Plates2Cleared 510(K)
- K142151SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K141651SENSITITRE SUSCEPTIBILITY PLATES2Cleared 510(K)
- K133847SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES2Cleared 510(K)
- K141000SENSITITRE SUSCEPTIBILITY PLATES2Cleared 510(K)
- K140985SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES2Cleared 510(K)
- K133773SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM2Cleared 510(K)
- K121002ETEST CEFTAROLINE2Cleared 510(K)
- K112276VIZION2Cleared 510(K)
- K111615SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K111429SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...2Cleared 510(K)
- K102535ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML2Cleared 510(K)
- K102668ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML2Cleared 510(K)
- K093604ETEST MOXIFLOXACIN 0.002-32 UG/ML2Cleared 510(K)
- K093741SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES2Cleared 510(K)
- K093865SENSITITRE 18-24HR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K092445SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K083606SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES2Cleared 510(K)
- K081520SENSITITRE VIZION2Cleared 510(K)
- K081182MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN2Cleared 510(K)
- K081325ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML2Cleared 510(K)
- K073653SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE2Cleared 510(K)
- K073558SENSITITRE 18-24 SUSCEPTIBILITY PLATE2Cleared 510(K)
- K073424SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K062841SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES2Cleared 510(K)
- K062839MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K062816SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K062783SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K062722SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K062681SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K062022HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K062190SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES2Cleared 510(K)
- K061687MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K061536MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K060783SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL2Cleared 510(K)
- K060621SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-2Cleared 510(K)
- K052366ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA2Cleared 510(K)
- K052091SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS2Cleared 510(K)
- K051202DRIED GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K043589MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM2Cleared 510(K)
- K042392DAPTOMYCIN2Cleared 510(K)
- K042390ETEST FOR GEMIFLOXACIN2Cleared 510(K)
- K042331PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K041776PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K041534SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K041214PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K040846SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES2Cleared 510(K)
- K040619SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES2Cleared 510(K)
- K032706MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML2Cleared 510(K)
- K033522SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES2Cleared 510(K)
- K033119PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K032518PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)2Cleared 510(K)
- K032382SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES2Cleared 510(K)
- K032259PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K031727PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN2Cleared 510(K)
- K031545SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE2Cleared 510(K)
- K031205PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K031103PASCO MIC AND MIC/ID PANELS (ERTAPENEM)2Cleared 510(K)
- K030933PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K023202MICROSCAN SYNERGIES PLUS2Cleared 510(K)
- K022656SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES2Cleared 510(K)
- K022775SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES2Cleared 510(K)
- K021997SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K021627SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K021181MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN2Cleared 510(K)
- K021018MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL2Cleared 510(K)
- K021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE2Cleared 510(K)
- K021188MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME2Cleared 510(K)
- K021169MICROSTREP PLUS PANEL, AZITHROMYCIN2Cleared 510(K)
- K021110MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE2Cleared 510(K)
- K020938MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM2Cleared 510(K)
- K020859CEFOTAXIME2Cleared 510(K)
- K020820MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME2Cleared 510(K)
- K021339HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE2Cleared 510(K)
- K020762GATIFLOXIN2Cleared 510(K)
- K020822MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN2Cleared 510(K)
- K021037MICROSTREP PLUS PANEL WITH AMPICILLIN2Cleared 510(K)
- K020937MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID2Cleared 510(K)
- K020686MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE2Cleared 510(K)
- K020691MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR2Cleared 510(K)
- K020748ETEST ERTAPENEM2Cleared 510(K)
- K020556MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN2Cleared 510(K)
- K014259SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K020037DRIED GRAM NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K020331PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K020162DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN2Cleared 510(K)
- K014258SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K013925SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES2Cleared 510(K)
- K013580SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE2Cleared 510(K)
- K013423MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS2Cleared 510(K)
- K013075SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K012921SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K012895HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE2Cleared 510(K)
- K012565SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K012151HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K011803SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES2Cleared 510(K)
- K010363ETEST MEROPENEM2Cleared 510(K)
- K004045SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K003868SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS2Cleared 510(K)
- K003834SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS2Cleared 510(K)
- K001953PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K001887MODIFICATION TO PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K001547ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP2Cleared 510(K)
- K001558SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)2Cleared 510(K)
- K001612PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K001573SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES2Cleared 510(K)
- K001516PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K001036SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)2Cleared 510(K)
- K001035SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)2Cleared 510(K)
- K000596ETEST GATIFLOXACIN2Cleared 510(K)
- K000298ETEST MOXIFLOXACIN2Cleared 510(K)
- K983943MICROSTREP PLUS PANEL, LEVOFLOXACIN2Cleared 510(K)
- K993679MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN2Cleared 510(K)
- K983953MICROSTREP PLUS PANEL, VANCOMYCIN2Cleared 510(K)
- K983746MICROSTREP PLUS PANEL2Cleared 510(K)
- K992296PASCO MIC AND MIC/ID PANELS, VANCOMYCIN2Cleared 510(K)
- K992143MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)2Cleared 510(K)
- K992108PASCO MIC AND MIC/ID PANELS (CEFEPIME)2Cleared 510(K)
- K992059PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K991925PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K983922DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K983408DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K983711DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K990722ETEST FOR CEFUROXIME2Cleared 510(K)
- K990685TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)2Cleared 510(K)
- K990297ETEST MINOCYCLINE2Cleared 510(K)
- K984581SYSTEM U3 FOR CEPHALOTHIN2Cleared 510(K)
- K984491SYSTEM U3 FOR CEFUROXIME2Cleared 510(K)
- K983890SYSTEM U32Cleared 510(K)
- K984489SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K984144SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID2Cleared 510(K)
- K984087SYSTEM U3 FOR AMPICILLIN2Cleared 510(K)
- K983565SYSTEM U3 FOR NITROFURANTOIN2Cleared 510(K)
- K983571SYSTEM U3 FOR TETRACYCLINE2Cleared 510(K)
- K983486SYSTEM U3 FOR NORFLOXACIN2Cleared 510(K)
- K983301SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN2Cleared 510(K)
- K983259SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE2Cleared 510(K)
- K983252SYSTEM U3 FOR GENTAMICIN2Cleared 510(K)
- K983027TRIMETHOPRIM/SULPHAMETHOXAZOLE2Cleared 510(K)
- K982868ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE2Cleared 510(K)
- K981639SYSTEM U3 FOR CIPROFLOXACIN2Cleared 510(K)
- K980877ETEST CEFDINIR2Cleared 510(K)
- K980335ETEST BENZYLPENICILLIN2Cleared 510(K)
- K981136ETEST FOSFOMYCIN2Cleared 510(K)
- K981135ETEST BENZYLPENICILLIN2Cleared 510(K)
- K981137ETEST CEFOTAXIME2Cleared 510(K)
- K981138ETEST CIPROFLOXACIN2Cleared 510(K)
- K981139ETEST CEFTRIAXONE2Cleared 510(K)
- K980342ETEST CHLORAMPHENICAL2Cleared 510(K)
- K980348ETEST VANCOMYCIN2Cleared 510(K)
- K981134ETEST TETRACYCLINE2Cleared 510(K)
- K980338ETEST OFLOXACIN2Cleared 510(K)
- K980345ETEST CEFTRIAXONE2Cleared 510(K)
- K980347ETEST TETRACYCLINE2Cleared 510(K)
- K980773ETEST GREPAFLOXACIN2Cleared 510(K)
- K980603ETEST TROVAFLOXACIN2Cleared 510(K)
- K974362PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K973695PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K972688MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN2Cleared 510(K)
- K972524DRIED GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K972567PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K971951PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K972180DRIED GRAM-NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K971697ETEST FOR LEVOFLOXACIN2Cleared 510(K)
- K971694ETEST FOR CEFTAZIDIME2Cleared 510(K)
- K971376DRIED GRAM-NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K970676DRIED GRAM-NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K970473ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE2Cleared 510(K)
- K970210AMIKACIN2Cleared 510(K)
- K964236(MODIFIED) ETEST PACKAGE INSERT2Cleared 510(K)
- K970820ETEST SPARFLOXACIN2Cleared 510(K)
- K965190SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE2Cleared 510(K)
- K964203PIPERACILLIN/TAZOBACTAM 42Cleared 510(K)
- K963641STREPTOCOCCUS MIC PANEL2Cleared 510(K)
- K963107ETEST FOR CEFEPIME2Cleared 510(K)
- K960991ETEST SUBMISSION FOR AMOXICILLIN2Cleared 510(K)
- K962867SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K962794ETEST FOR AZTREONAM2Cleared 510(K)
- K961517ETEST SUBMISSION FOR CEFOTETAN2Cleared 510(K)
- K961519ETEST SUBMISSION FOR AZITHROMYCIN2Cleared 510(K)
- K960989ETEST SUBMISSION FOR IMIPENEM2Cleared 510(K)
- K960990ETEST SUBMISSION FOR VANCOMYCIN2Cleared 510(K)
- K960235SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K960220SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K955910DRIED GRAM-NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K955920THE E TEST CEFTIZOXIME2Cleared 510(K)
- K954319AMOXICILLIN/CLAVULANIC ACID 2/12Cleared 510(K)
- K953422FOX FASTIDIOUS TEST PANELS2Cleared 510(K)
- K951240JUSTONE2Cleared 510(K)
- K951241HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE2Cleared 510(K)
- K953223PIPERACILIN TAZOBACTAM 4 UG2Cleared 510(K)
- K934458DRIED GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K936305SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES2Cleared 510(K)
- K951879TICARCILLIN/CLAVULANIC ACID 22Cleared 510(K)
- K951539ENTEROCOCCUS SCREENING MEDIUM2Cleared 510(K)
- K946364E TEST FOR OFLOXACIN2Cleared 510(K)
- K950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI2Cleared 510(K)
- K950328AMOXICILLIN/CLAVULANIC ACID 2/12Cleared 510(K)
- K950123SCEPTOR SYSTEM PANELS2Cleared 510(K)
- K945433ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS2Cleared 510(K)
- K944753SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP2Cleared 510(K)
- K943756MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE2Cleared 510(K)
- K945997MODIFIED FOX EXTRA GRAM POSITIVE2Cleared 510(K)
- K935485FAS FASTIDIOUS MIC PANEL2Cleared 510(K)
- K940917LORACARBEF GRAM-NAGATIVE PANELS2Cleared 510(K)
- K941459GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX2Cleared 510(K)
- K941317DRIED GRAM NEGATIVE/CEFMETAZOLE2Cleared 510(K)
- K941997BBL CRYSTAL MRSA ID SYSTEM2Cleared 510(K)
- K946126PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K942267DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE2Cleared 510(K)
- K942089MICRODILUTION/LORACARBEF PANELS2Cleared 510(K)
- K943510DRIED GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K944651DRIED GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K935519ETEST FOR AMPICILLIN/SULBACTAM 2/12Cleared 510(K)
- K944723ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION2Cleared 510(K)
- K944517PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K934323DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL2Cleared 510(K)
- K934380PASCO MIC PANELS/ GENT & STREP SYNERGY2Cleared 510(K)
- K933746PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K933709PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K933885ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K933849PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K932917PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K932082DRIED GRAM-NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K930469ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K926294BBL CRYSTAL MRSA ID SYSTEM2Cleared 510(K)
- K931069PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K930055ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K926545DRIED GRAM-NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K923045SENSITITRE SUSCEPTIBILITY PLATES2Cleared 510(K)
- K925644CATION ADJUSTED MUELLER HINTON BROTH2Cleared 510(K)
- K922458DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K923684API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC2Cleared 510(K)
- K924500ANTIMICROBIAL SUSCEPTIBILITY TEST2Cleared 510(K)
- K922926API UNISCEPT KB/TYPE 2 AND 32Cleared 510(K)
- K922780ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K922003ANTIMICROBIAL SUSCETIBILITY TEST PANEL2Cleared 510(K)
- K922168ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K912778HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE2Cleared 510(K)
- K913459THE E TEST, MODIFICATION2Cleared 510(K)
- K912965API UNISCEPT KB2Cleared 510(K)
- K912964API UNISCEPT MIC/UNISCEPT MICRO-MIC2Cleared 510(K)
- K912613GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)2Cleared 510(K)
- K912846JUSTONE(TM)2Cleared 510(K)
- K911558ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN2Cleared 510(K)
- K911389ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM)2Cleared 510(K)
- K911390ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM)2Cleared 510(K)
- K911391ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME)2Cleared 510(K)
- K911392ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN2Cleared 510(K)
- K911556ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL.2Cleared 510(K)
- K911559ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICID2Cleared 510(K)
- K911557ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN2Cleared 510(K)
- K911555ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL.2Cleared 510(K)
- K911305ANTIMICROBIAL GENTAMICIN2Cleared 510(K)
- K911304ANTIMICROBIAL TOBRAMYCIN2Cleared 510(K)
- K911185ANTIMICROBIAL AMPICILLIN2Cleared 510(K)
- K911303ANTIMICROBIAL AMIKACIN2Cleared 510(K)
- K911187ANTIMICROBIAL CEFUROXIME2Cleared 510(K)
- K911186ANTIMICROBIAL AMPICILLIN/SULBACTAM2Cleared 510(K)
- K910484ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K910242EF SYNERGY QUAD MODIFIED2Cleared 510(K)
- K910346ANTIMICROBIAL CEFTRIAXONE2Cleared 510(K)
- K910345ANTIMICROBIAL CEFOPERAZONE2Cleared 510(K)
- K905853ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K904689ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS2Cleared 510(K)
- K904523ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED2Cleared 510(K)
- K903589EF SYNERGY QUAD2Cleared 510(K)
- K901598FASTIDIOUS MIC PANEL2Cleared 510(K)
- K902739PASCO MIC AND MIC/ID MODIFIED2Cleared 510(K)
- K896278SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN2Cleared 510(K)
- K896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE2Cleared 510(K)
- K896332SUPPLEMENT TO ANAEROBIC MIC PANEL2Cleared 510(K)
- K896965ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K895215PASCO MIC/ID GRAM-POSITIVE PANEL2Cleared 510(K)
- K895796API UNISCEPT KB2Cleared 510(K)
- K894514ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL2Cleared 510(K)
- K894189SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID2Cleared 510(K)
- K894146GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K893977GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K884831ANAEROBIC MIC PANEL2Cleared 510(K)
- K884510MODIFICATION MICRO-MIC2Cleared 510(K)
- K884509MODIFICATION MIC/API UNISCEPT(R)2Cleared 510(K)
- K883798SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL2Cleared 510(K)
- K883800SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL2Cleared 510(K)
- K883551SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #803252Cleared 510(K)
- K883554SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #803292Cleared 510(K)
- K883553SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #803312Cleared 510(K)
- K883552SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 803282Cleared 510(K)
- K883550SCEPTOR STAPHYLOCOCCUS MIC #803242Cleared 510(K)
- K883548SCEPTOR STREPTOCOCCUS MIC/ID PANEL #803232Cleared 510(K)
- K883549SCEPTOR STREPTOCOCCUS MIC PANEL #803222Cleared 510(K)
- K883555SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #803322Cleared 510(K)
- K882477ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL2Cleared 510(K)
- K883394GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K883076GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K882909SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN2Cleared 510(K)
- K882912SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM2Cleared 510(K)
- K882911SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN2Cleared 510(K)
- K882910SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC2Cleared 510(K)
- K882299SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL2Cleared 510(K)
- K881716SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR2Cleared 510(K)
- K882301SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88)2Cleared 510(K)
- K882300SCEPTOR ENTERIC MIC PANEL (REVISED 4/88)2Cleared 510(K)
- K881846SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN2Cleared 510(K)
- K882029LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K880641SENSITITRE STABILITY PLATES2Cleared 510(K)
- K880430GRAM NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K880598MODIFICATIONS TO API UNISCEPT (R) KB2Cleared 510(K)
- K880617ADDITION OF AMPICILLIN/SULBACTAM & CIPROFLOXACIN2Cleared 510(K)
- K874727PRECEPT(TM) CIPROFLOXACIN2Cleared 510(K)
- K874876GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL2Cleared 510(K)
- K874466API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC2Cleared 510(K)
- K874426NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO2Cleared 510(K)
- K870719SENSIR SYSTEM2Cleared 510(K)
- K870074GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K870663API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC2Cleared 510(K)
- K864891API UNISCEPT (TM) KB2Cleared 510(K)
- K864493REVISED RESISTANT 5 MIC PANEL2Cleared 510(K)
- K863776MICRODILUTION MIC PANELS2Cleared 510(K)
- K863847MIC - CONCEPT(TM) RX-22Cleared 510(K)
- K864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID2Cleared 510(K)
- K862978RESISTANT 6 MIC PANEL2Cleared 510(K)
- K862140MICRODILUTION PANELS2Cleared 510(K)
- K862560PRECEPT CEFTIZOXIME2Cleared 510(K)
- K862446PRECEPT CEFTAZIDIME2Cleared 510(K)
- K861584GRAM NEGATIVE COMBO PANEL TYPE 32Cleared 510(K)
- K861187SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL2Cleared 510(K)
- K861186SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL2Cleared 510(K)
- K861408MODIFIED UNISCEPT KB LABELING AMENDMENT2Cleared 510(K)
- K860753SENSITITRE SUSCEPTIBILITY PLATES2Cleared 510(K)
- K854525FOX FASTIDIOUS TEST PANEL2Cleared 510(K)
- K853805MICRO-MEDIA MICRODILUTION TEST PANELS2Cleared 510(K)
- K860369API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC2Cleared 510(K)
- K860195PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE2Cleared 510(K)
- K854577PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)2Cleared 510(K)
- K853862PASCO RESISTANT 5 PANEL2Cleared 510(K)
- K854098SCEPTOR PSEUDOMONAS PLUS MIC PANEL2Cleared 510(K)
- K854103SCEPTOR ENTERIC MIC/ID PANEL2Cleared 510(K)
- K854102SCEPTOR ENTERIC MIC PANEL2Cleared 510(K)
- K854101SCEPTOR GRAM POSITIVE MIC PANEL2Cleared 510(K)
- K854100SCEPTOR GRAM POSITIVE MIC/ID PANEL2Cleared 510(K)
- K854099SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL2Cleared 510(K)
- K854097SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL2Cleared 510(K)
- K850833PRECEPT TM MEZLOCILLIN2Cleared 510(K)
- K844903MIC-BIO-PLATE2Cleared 510(K)
- P830028UNISCEPT(TM)2PMA Approval
- P830028UNISCEPT(TM)2PMA Approval
- K801805METRONIDAZOLE DISCS2Cleared 510(K)
- LIEReagent/Device, Inoculum Calibration2Product Code
- LKACulture Media, Antimicrobial Susceptibility Test2Product Code
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation2Product Code
- LOPSolution, Antimicrobial2Product Code
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems2Product Code
- LTTPanels, Test, Susceptibility, Antimicrobial2Product Code
- LTWSusceptibility Test Cards, Antimicrobial2Product Code
- LTXDiscs, Elution2Product Code
- MJASusceptibility Test Powders, Antimycobacterial2Product Code
- MJDCulture Media, Antimycobacteria, Susceptibility Test2Product Code
- MJECulture Media, Antifungal, Susceptibility Test2Product Code
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies2Product Code
- NGZSusceptibility Test Plate, Antifungal2Product Code
- NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus Species2Product Code
- NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen2Product Code
- PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony2Product Code
- POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen2Product Code
- PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates2Product Code
- QIVCulture-Based Short-Term Incubation Antimicrobial Resistance Assay2Product Code
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192050
- 510(k) Type
- Traditional
- Applicant
- bioMerieux SA
- Country
- France
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/27/2019
- Days to Decision
- 58 days
- Submission Type
- Summary