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
- LIEReagent/Device, Inoculum Calibration2Product Code
- LKACulture Media, Antimicrobial Susceptibility Test2Product Code
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation2Product Code
- K234012VITEK COMPACT PRO2Cleared 510(K)
- K250344BD Phoenix™ Automated Microbiology System2Cleared 510(K)
- K233986BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)2Cleared 510(K)
- K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)2Cleared 510(K)
- K232756Colibrí2Cleared 510(K)
- K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin2Cleared 510(K)
- K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin2Cleared 510(K)
- K222378VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)2Cleared 510(K)
- K211748Selux AST System; Model AST Gen 1.02Cleared 510(K)
- K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin2Cleared 510(K)
- K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin2Cleared 510(K)
- K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)2Cleared 510(K)
- K223481VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)2Cleared 510(K)
- K220803VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin2Cleared 510(K)
- K211759Selux AST System; Model AST Gen 1.02Cleared 510(K)
- K220805VITEK 2 AST-Gram Positive Cefoxitin Screen2Cleared 510(K)
- K220546Colibrí System2Cleared 510(K)
- K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)2Cleared 510(K)
- K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin2Cleared 510(K)
- K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)2Cleared 510(K)
- K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)2Cleared 510(K)
- K213241VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole2Cleared 510(K)
- K212849VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)2Cleared 510(K)
- K210287VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)2Cleared 510(K)
- K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)2Cleared 510(K)
- K211630VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)2Cleared 510(K)
- K201675VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)2Cleared 510(K)
- K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)2Cleared 510(K)
- K193299VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)2Cleared 510(K)
- K201405LabPro Data Management System2Cleared 510(K)
- K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)2Cleared 510(K)
- K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)2Cleared 510(K)
- K193567VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)2Cleared 510(K)
- K192110Vitek Densichek2Cleared 510(K)
- K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)2Cleared 510(K)
- K190905BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)2Cleared 510(K)
- K190616VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)2Cleared 510(K)
- K183524VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)2Cleared 510(K)
- K183551VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)2Cleared 510(K)
- K183360VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)2Cleared 510(K)
- K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)2Cleared 510(K)
- K181766VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance2Cleared 510(K)
- K181665BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN2Cleared 510(K)
- K173523BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)2Cleared 510(K)
- K173252BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)2Cleared 510(K)
- K172944VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL2Cleared 510(K)
- K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)2Cleared 510(K)
- K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)2Cleared 510(K)
- K163637BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)2Cleared 510(K)
- K163563VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)2Cleared 510(K)
- K161437VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)2Cleared 510(K)
- K161510VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)2Cleared 510(K)
- K163083VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)2Cleared 510(K)
- K163006VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)2Cleared 510(K)
- K161217VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)2Cleared 510(K)
- K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)2Cleared 510(K)
- K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)2Cleared 510(K)
- K151320BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml2Cleared 510(K)
- K142170BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP2Cleared 510(K)
- K141149VITEK 2 AST GP CEFTAROLINE2Cleared 510(K)
- K140468BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)2Cleared 510(K)
- K132909BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)2Cleared 510(K)
- K132674BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)2Cleared 510(K)
- K132507VITEK 2 AST ST MEROPENEM2Cleared 510(K)
- K131779VITEK 2 AST-ST TIGECYCLINE2Cleared 510(K)
- K132573VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN2Cleared 510(K)
- K131331BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)2Cleared 510(K)
- K123404BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)2Cleared 510(K)
- K123266BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN2Cleared 510(K)
- K121546VITEK 2 GRAM NEGATIVE DOXYCYCLINE2Cleared 510(K)
- K121100VITEK 2 AST STREPTOCOCUS VANCOMYCIN2Cleared 510(K)
- K122547GRAM POSTITVE CLINDAMYCIN2Cleared 510(K)
- K122359VITEK 2 STRPTOCOCCUS CEFTRIAXONE2Cleared 510(K)
- K121863VITEK 2 AST-ST CEFOTAXIME2Cleared 510(K)
- K113783VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE2Cleared 510(K)
- K113200VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM2Cleared 510(K)
- K111893VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE2Cleared 510(K)
- K111976VITEK 2 STREPTOCOCCUS ERYTHROMYCIN2Cleared 510(K)
- K113305VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE2Cleared 510(K)
- K110106VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE2Cleared 510(K)
- K112000VITEK 2 STREPTOCOCCUS PENICILLIN2Cleared 510(K)
- K111909VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE2Cleared 510(K)
- K103752VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE2Cleared 510(K)
- K112228VITEK 2 STREPTOCOCCUS LEVOFLOXACIN2Cleared 510(K)
- K112129VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN2Cleared 510(K)
- K112075VITEK 2 STRPTOCOCCUS AMPICILLIN2Cleared 510(K)
- K111599VITEK 2 AST-ST LINEZOLID2Cleared 510(K)
- K093076VITEK 2 GRAM POSITIVE DOXCYCLINE2Cleared 510(K)
- K093224DENSICHECK PLUS2Cleared 510(K)
- K092919MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B10252Cleared 510(K)
- K083536DENSICHEK PLUS2Cleared 510(K)
- K091899VITEK 2 GRAM NEGATIVE MEROPENEM2Cleared 510(K)
- K091126VITEK 2 GRAM POSITIVE DAPTOMYCIN2Cleared 510(K)
- K082346VITEK 2 GRAM NEGATIVE DORIPENEM2Cleared 510(K)
- K083383VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE2Cleared 510(K)
- K082852BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML2Cleared 510(K)
- K082913BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML2Cleared 510(K)
- K082538BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST2Cleared 510(K)
- K080201VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE2Cleared 510(K)
- K073589BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS2Cleared 510(K)
- K080107VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM2Cleared 510(K)
- K073406VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE2Cleared 510(K)
- K073433BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML2Cleared 510(K)
- K073083VITEK 2 GRAM NEGATIVE PIPERACILLIN2Cleared 510(K)
- K072695VITEK 2 GRAM POSITIVE TIGECYCLINE2Cleared 510(K)
- K072668VITEK 2 GRAM POSITIVE VANCOMYCIN2Cleared 510(K)
- K070809BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML2Cleared 510(K)
- K072038VITEK 2 GRAM NEGATIVE LEVOFLOXACIN2Cleared 510(K)
- K071623BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML2Cleared 510(K)
- K071317MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN2Cleared 510(K)
- K070346DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM2Cleared 510(K)
- K071268MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE2Cleared 510(K)
- K071076SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K070860MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN2Cleared 510(K)
- K063486BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY2Cleared 510(K)
- K063824BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML2Cleared 510(K)
- K063811BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML2Cleared 510(K)
- K063564MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML)2Cleared 510(K)
- K063300BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML2Cleared 510(K)
- K063597VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE2Cleared 510(K)
- K063623VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE2Cleared 510(K)
- K063573BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML2Cleared 510(K)
- K063492VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE2Cleared 510(K)
- K063365SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE2Cleared 510(K)
- K063366MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE2Cleared 510(K)
- K063301BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML2Cleared 510(K)
- K062945BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML2Cleared 510(K)
- K062938MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML2Cleared 510(K)
- K062944BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML2Cleared 510(K)
- K062687BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML2Cleared 510(K)
- K062705SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID2Cleared 510(K)
- K062680BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML2Cleared 510(K)
- K062207BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML2Cleared 510(K)
- K062206BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML2Cleared 510(K)
- K061869BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML2Cleared 510(K)
- K061867BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML2Cleared 510(K)
- K061673BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML2Cleared 510(K)
- K061327BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0.2Cleared 510(K)
- K061347VITEK 2 GRAM POSITIVE VRSA SCREEN2Cleared 510(K)
- K061355BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML2Cleared 510(K)
- K060324BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE2Cleared 510(K)
- K060558BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML2Cleared 510(K)
- K060447BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN)2Cleared 510(K)
- K060257BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML2Cleared 510(K)
- K060444BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML2Cleared 510(K)
- K060217BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML2Cleared 510(K)
- K060493BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA.2Cleared 510(K)
- K060312MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML)2Cleared 510(K)
- K060218BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML2Cleared 510(K)
- K060214BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML2Cleared 510(K)
- K053504MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)2Cleared 510(K)
- K060088MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN2Cleared 510(K)
- K053241BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML2Cleared 510(K)
- K053097VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN2Cleared 510(K)
- K053186VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE2Cleared 510(K)
- K052656VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN2Cleared 510(K)
- K052346SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K052270BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML2Cleared 510(K)
- K052269BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN2Cleared 510(K)
- K052250BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML2Cleared 510(K)
- K052311VITEK 2 GRAM NEGATIVE TIGECYCLINE2Cleared 510(K)
- K051849VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE2Cleared 510(K)
- K051689BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML2Cleared 510(K)
- K051478MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN2Cleared 510(K)
- K051350SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K051692BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML2Cleared 510(K)
- K051311MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN2Cleared 510(K)
- K051272BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML2Cleared 510(K)
- K051266BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML2Cleared 510(K)
- K051204BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML2Cleared 510(K)
- K051183BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML2Cleared 510(K)
- K051109BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML2Cleared 510(K)
- K051138BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML2Cleared 510(K)
- K050946BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML2Cleared 510(K)
- K050982BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)2Cleared 510(K)
- K050976VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE2Cleared 510(K)
- K050865BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML2Cleared 510(K)
- K050881BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML2Cleared 510(K)
- K050816VITEK 2 GRAM POSITIVE MEROPENEM2Cleared 510(K)
- K050780BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML2Cleared 510(K)
- K050747BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML2Cleared 510(K)
- K050745BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML2Cleared 510(K)
- K050555BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML2Cleared 510(K)
- K050400BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML2Cleared 510(K)
- K043458BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML2Cleared 510(K)
- K050089BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML2Cleared 510(K)
- K050075VITEK 2 GRAM POSITIVE DAPTOMYCIN2Cleared 510(K)
- K050076VITEK 2 GRAM POSITIVE ERTAPENEM2Cleared 510(K)
- K050002VITEK 2 COMPACT2Cleared 510(K)
- K043389BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML2Cleared 510(K)
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- K023568BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM2Cleared 510(K)
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- K023527BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML2Cleared 510(K)
- K023858BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM2Cleared 510(K)
- K023361MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)2Cleared 510(K)
- K023541MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)2Cleared 510(K)
- K023444BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML2Cleared 510(K)
- K023301BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM2Cleared 510(K)
- K023273BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML2Cleared 510(K)
- K022045VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID2Cleared 510(K)
- K022172BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM2Cleared 510(K)
- K021954BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML2Cleared 510(K)
- K022129BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML2Cleared 510(K)
- K020413MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML)2Cleared 510(K)
- K020410MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML)2Cleared 510(K)
- K020321BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM2Cleared 510(K)
- K020398MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)2Cleared 510(K)
- K020397MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML)2Cleared 510(K)
- K020506MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)2Cleared 510(K)
- K020319MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)2Cleared 510(K)
- K020323BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM2Cleared 510(K)
- K020871VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN2Cleared 510(K)
- K020322BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM2Cleared 510(K)
- K020870VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN2Cleared 510(K)
- K020248MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)2Cleared 510(K)
- K020142MICROSCAN SYNERGIES PLUS2Cleared 510(K)
- K020511MICROSCAN SYNERGIES PLUS2Cleared 510(K)
- K020328MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)2Cleared 510(K)
- K020249MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)2Cleared 510(K)
- K020246MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)2Cleared 510(K)
- K020209MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML)2Cleared 510(K)
- K020185MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)2Cleared 510(K)
- K020182MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML)2Cleared 510(K)
- K020173MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)2Cleared 510(K)
- K020168MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)2Cleared 510(K)
- P870049MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN(R) RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN(R) RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049RAPID POSITIVE MIC PANEL2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN(R)2PMA Approval
- P870049MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS2PMA Approval
- P870049MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS2PMA Approval
- P870049MICROSCAN(R)2PMA Approval
- P870049MICROSCAN(R)2PMA Approval
- P870049MICROSCAN(R) WALKAWAY(TM)-402PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- K891577SCEPTOR DATA MANAGEMENT CENTER SOFTWARE2Cleared 510(K)
- P870049MICROSCAN RAPID FLUOROGENIC PANELS2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- P810024AUTOBAC MTS PLUS TEST SYTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- P870049MICROSCAN RAPID PANELS2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- K861958REPLIANALYZER2Cleared 510(K)
- P840065COBAS BACT2PMA Approval
- P810024AUTOBAC MTS PLUS TEST SYTEM2PMA Approval
- P810024AUTOBAC MTS PLUS TEST SYTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- P800030BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- P800029API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM2PMA Approval
- P800029API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM2PMA Approval
- N50531SENSITITRE2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- P810024AUTOBAC MTS PLUS TEST SYTEM2PMA Approval
- P800029API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM2PMA Approval
- P800029API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- P800029OMNISCEPT(TM) KB SYSTEM2PMA Approval
- P820073MICUR-MIC SYSTEMS2PMA Approval
- P800030BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC2PMA Approval
- P800030BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- P800030BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50531SENSITITRE2PMA Approval
- P800030BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- P800029API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50531SENSITITRE2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- P810024AUTOBAC MTS PLUS TEST SYTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- P800030BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC2PMA Approval
- P800029API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50487UTI MIC TEST PANEL2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N505383M BRAND MICROBIAL PROFILE SYSTEM2PMA Approval
- N50531SENSITITRE2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- P800029API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS2PMA Approval
- P800030BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC2PMA Approval
- P800029API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50531SENSITITRE2PMA Approval
- N50538FLOW MIC SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50524MIC TEST SYSTEM2PMA Approval
- N50524MIC TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50525MS 2 MICROBIAL SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50531SENSITITRE2PMA Approval
- N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM2PMA Approval
- N50524AUTOBAC MIC TEST SYSTEM2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50487MIC TEST PANELS2PMA Approval
- N50061POLYMYXIN B SULFATE SUSCEPTIBILITY TESTING2PMA Approval
- 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
POLYMYXIN B SULFATE SUSCEPTIBILITY TESTING
- Page Type
- PMA Approval
- Applicant
- PFIZER, INC.
- Trade Name
- POLYMYXIN B SULFATE SUSCEPTIBILITY TESTING
- Generic Name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Decision Date
- 11/24/1969
- Days to Decision
- 0 days
- Decision Code
- APRL
- FDA Decision
- Reclassification after approval