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
- K241060HardyDisk AST Cefiderocol 30µg (FDC30)2Cleared 510(K)
- K231806Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF52Cleared 510(K)
- K232276Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD202Cleared 510(K)
- K231568HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)2Cleared 510(K)
- K230651BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)2Cleared 510(K)
- K230827HardyDisk AST Rezafungin 5µg (RZF5)2Cleared 510(K)
- K221826BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)2Cleared 510(K)
- K203336Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC302Cleared 510(K)
- K210873Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU202Cleared 510(K)
- K203700Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC302Cleared 510(K)
- K193508Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV202Cleared 510(K)
- K193504HardyDisk AST Cefiderocol 30ug (FDC30)2Cleared 510(K)
- K192326HardyDisk AST Lefamulin 20µg (LMU20)2Cleared 510(K)
- K191931HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)2Cleared 510(K)
- K183298HardyDisk AST Omadacycline 30µg (OMC30)2Cleared 510(K)
- K181975Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV302Cleared 510(K)
- K182357HardyDisk AST Eravacycline 20µg (ERV20)2Cleared 510(K)
- K181700HardyDisk AST Plazomicin 30ug (PLZ30)2Cleared 510(K)
- K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)2Cleared 510(K)
- K171975HardyDisk AST Delafloxacin 5 µg (DLX5)2Cleared 510(K)
- K170127HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T402Cleared 510(K)
- K152838HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA502Cleared 510(K)
- K152846HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T402Cleared 510(K)
- K152516BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks2Cleared 510(K)
- K112586CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)2Cleared 510(K)
- K103538HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z9392Cleared 510(K)
- K100722TELAVANCIN 30 UG, BBL SENSI-DISC2Cleared 510(K)
- K093807HARDYDISK AST TELAVANCIN,30UG2Cleared 510(K)
- K082271FLUCONAZOLE 25UG BBL SENSI-DISC2Cleared 510(K)
- K082272VORICONAZOLE 1UG BBL SENSI-DISC2Cleared 510(K)
- K080998DORIPENEM 10UG BBL SENSI-DISC2Cleared 510(K)
- K080019HARDYDISK AST DORIPENEM 10 UG2Cleared 510(K)
- K070262ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K062245HARDY DISK AST TIGECYCLINE 15 UG, MODELZ9362Cleared 510(K)
- K060286TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K052853TIGECYCLINE 15UG BBL SENSI-DISC2Cleared 510(K)
- K052876TELITHROMYCIN 15UG BBL SENSI-DISC2Cleared 510(K)
- K050062GEMIFLOXACIN, 5UG BBL SENSI-DISC2Cleared 510(K)
- K042157DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K020842ERTAPENEM 10UG BBL SENSI-DISC2Cleared 510(K)
- K011384HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z8832Cleared 510(K)
- K011385HARDKYDISK NEOMYCIN, 30 MCG2Cleared 510(K)
- K011086HARDYDISK BACITRACIN, 10MCG, MODEL Z9272Cleared 510(K)
- K010536MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K010537LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K003690HARDYDISK SULFISOXAZOLE2Cleared 510(K)
- K003554HARDYDISK TRIMETHOPRIM 5MCG2Cleared 510(K)
- K003556HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG2Cleared 510(K)
- K003686HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG2Cleared 510(K)
- K003536HARDYDISK NAFCILLIN, 1 MCG2Cleared 510(K)
- K003537HARDYDISK RIFAMPIN, 5MCG2Cleared 510(K)
- K003532HARDY DISK, CEFPODOXINE, 10MCG2Cleared 510(K)
- K002662HARDYDISK CLINDAMYCIN, 2MCG2Cleared 510(K)
- K002661HARDYDISK CEFOTETAN, 30MCG2Cleared 510(K)
- K002660HARDYDISK LOMEFLOXACIN, 10MCG2Cleared 510(K)
- K002664HARDYDISK LEVOFLOXACIN, 5MCG2Cleared 510(K)
- K002367HARDY DISK CEFTIZOXIME, 30MCG2Cleared 510(K)
- K002369HARDYDISK GENTAMICIN, 120MCG2Cleared 510(K)
- K002656HARDYDISK CEFUROXIME, 30MCG2Cleared 510(K)
- K002368HARDYDISK STREPTOMYCIN, 300MCG2Cleared 510(K)
- K002663HARDYDISK NETILMICIN, 30MCG2Cleared 510(K)
- K002165LINEZOLID, 30UG, BBL SENSI-DISC2Cleared 510(K)
- K001728HARDY DISK CLARITHROMYCIN, 15MCG2Cleared 510(K)
- K001487HARDYDISK CINOXACIN, 100 MCG2Cleared 510(K)
- K001490HARDYDISK CEFONICID, 30 MCG2Cleared 510(K)
- K001489HARDYDISK CEFOPERAZONE, 75 MCG2Cleared 510(K)
- K000930GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K000928QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC2Cleared 510(K)
- K000829GATIFLOXACIN, 5 UG, BBL SENSI-DISC2Cleared 510(K)
- K000526HARDYDISK, CEPHALOTHIN 30MCG2Cleared 510(K)
- K000525HARDYDISK OFLOXACIN 5MCG2Cleared 510(K)
- K000524HARDYDISK, CEFOTAXIME 30MCG2Cleared 510(K)
- K000509HARDYDISK, VANCOMYCIN 30MCG2Cleared 510(K)
- K000440HARDYDISK CEFTRIAXONE 30MCG2Cleared 510(K)
- K000272HARDYDISK, NITROFURANTOIN2Cleared 510(K)
- K000261HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG2Cleared 510(K)
- K000268HARDYDISK, AMPICILLIN, 10MCG2Cleared 510(K)
- K000271HARDYDISK, SULFA/TRIMETH2Cleared 510(K)
- K000305HARDYDISK, CEFOXITIN, 30MCG2Cleared 510(K)
- K000304HARDYDISK, TETRACYCLINE 30MCG2Cleared 510(K)
- K000302HARDY DISK, PENICILLIN, 10 UNITS2Cleared 510(K)
- K000259HARDYDISK, CEFTAZIDIME, 30MCG2Cleared 510(K)
- K000258HARDYDISK, CIPROFLOXACIN, 5MCG2Cleared 510(K)
- K000203HARDYDISK, KANAMYCIN, 30MCG2Cleared 510(K)
- K000181HARDYDISK, CARBENICILLIN, 100MCG2Cleared 510(K)
- K000175HARDYDISK TICARILLIN 75MCG2Cleared 510(K)
- K000201HARDYDISK, STREPTOMYCIN 10MCG2Cleared 510(K)
- K000182HARDYDISK TOBRAMYCIN, 10MCG2Cleared 510(K)
- K000130HARDYDISK, NALIDIXIC ACID, 30MCG2Cleared 510(K)
- K000183HARDYDISK, PIPERACILLIN, 100MCG2Cleared 510(K)
- K000128HARDYDISK, CEFAZOLIN, 30MCG2Cleared 510(K)
- K000022HARDYDISK CEFAMANDOLE, 30MCG2Cleared 510(K)
- K994134HARDYDISK OXACILLIN, 1MCG2Cleared 510(K)
- K994150HARDYDISK NORFLOXACIN, 10MCG2Cleared 510(K)
- K994135HARDYDISK ERYTHROMYCIN, 15MCG2Cleared 510(K)
- K994212HARDYDISK MEZLOCILLIN 75MCG2Cleared 510(K)
- K994129HARDYDISK CEFIXIME, 5MCG2Cleared 510(K)
- K994089HARDYDISK CHLORAMPHENICOL, 30MCG2Cleared 510(K)
- K994091HARDYDISK GENTAMICIN, 10MCG2Cleared 510(K)
- K994046HARDYDISK CEFACLOR 30MCG2Cleared 510(K)
- K994132HARDYDISK IMIPENEM, 10MCG2Cleared 510(K)
- K994063HARDYDISK AZTREONAM, 30MCG2Cleared 510(K)
- K994067HARDY DISK AMPICILLIN/SULBACTAM2Cleared 510(K)
- K994051HARDYDISK DOXYCYCLINE, 30MCG2Cleared 510(K)
- K993993HARDYDISK AMIKACIN 30MCG2Cleared 510(K)
- K993994HARDYDISK AZITHROMYCIN 15MCG2Cleared 510(K)
- K993577CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC2Cleared 510(K)
- K992853PASCO MIC AND MIC/ID PANELS, CEFDINIR2Cleared 510(K)
- K993186SYNERCID, 15 UG, BBL SENSI-DISC2Cleared 510(K)
- K992726PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS2Cleared 510(K)
- K992717PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN2Cleared 510(K)
- K992646PASCO MIC AND MIC/ID PANELS, PENICILLIN2Cleared 510(K)
- K992647PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN2Cleared 510(K)
- K992593PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL2Cleared 510(K)
- K992568PASCO MIC AND MIC/ID PANELS, CEFOTAXIME2Cleared 510(K)
- K992562PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE2Cleared 510(K)
- K992546PASCO MIC AND MIC/ID PANELS, MEROPENEM2Cleared 510(K)
- K992507PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN2Cleared 510(K)
- K992420MODIFICATION OF PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K992297PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN2Cleared 510(K)
- K992077PASCO MIC AND MIC/ID PANELS (OFLOXACIN)2Cleared 510(K)
- K992076PASCO MIC AND MIC/ID PANELS (CEFUROXIME)2Cleared 510(K)
- K984513TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K984608GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K984036NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K983718MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K982669OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K982528NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K982517CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K982519LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K982520CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K982523SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K982524AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K982526SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K982235PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K981517CEFDINIR, 5 UG, SENSI-DISC2Cleared 510(K)
- K980955PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K980683TROVAFLOXACIN 10G, SENSI-DISC2Cleared 510(K)
- K974578GREPAFLOXACIN, 5 MG, SENSI-DISC2Cleared 510(K)
- K971636RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K974394ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K971637COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K973479CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K973488LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K973489LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K973487CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K971638CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K971632TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K972098FOSFOMYCIN, 200 MG, SENSI-DISC2Cleared 510(K)
- K971631CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K971635AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K971633PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K971120DISPENS-O-DISC (TM) LEVOFLOXACIN2Cleared 510(K)
- K971211DISPENS-O-DISC SPARFLOXACIN2Cleared 510(K)
- K970831REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK2Cleared 510(K)
- K970830REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK2Cleared 510(K)
- K970385SPARFLOZACIN, 5 MCG, SENSI-DISC2Cleared 510(K)
- K970212LEVOFLOXACIN, 5MCG, SENSI-DISC2Cleared 510(K)
- K964492CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K964495CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K964489CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K964490AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K964491NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K964487IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K964501SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K964496CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC2Cleared 510(K)
- K964493OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K964512CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC2Cleared 510(K)
- K965159CETIBUTEN, 30MCG, SENSI-DISC2Cleared 510(K)
- K964421REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK2Cleared 510(K)
- K963845MEROPENEM, 10 MCG, SENSI-DISC2Cleared 510(K)
- K963508DISPENS-O-DISC MEROPENEM2Cleared 510(K)
- K961818GENTAMICIN DISK (120MCG)2Cleared 510(K)
- K961819STREPTOMYCIN DISK (300MCG)2Cleared 510(K)
- K961188CEFEPIME, 30 MCG, SENSI-DISC2Cleared 510(K)
- K955669REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK2Cleared 510(K)
- K944275DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.2Cleared 510(K)
- K943407GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS2Cleared 510(K)
- K935975REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG2Cleared 510(K)
- K940359PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC2Cleared 510(K)
- K930702DRYSLIDE CEFIN2Cleared 510(K)
- K934100REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K933657REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K933118REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K932052ADAMS SCIENTIFIC SENSITIVITY DISCS2Cleared 510(K)
- K931799REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K931289REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K931290REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K931530BILE SPOT REAGENT2Cleared 510(K)
- K930946DISPENS-O-DISC CEFPODOXIME 10 MCG.2Cleared 510(K)
- K930911DISPENS-O-DISC CLARITHROMYCIN 15 MG.2Cleared 510(K)
- K925969ADAMS SCIENTIFIC SENSITIVITY DISCS2Cleared 510(K)
- K925060REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K924846REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K924797CEFPODOXIME 10 MCG, SENSI DISC2Cleared 510(K)
- K924765REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K924766REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K923952ENOXACIN 10 MCG. SENSI SISC2Cleared 510(K)
- K922793CEFZIL2Cleared 510(K)
- K922794ENOXACIN2Cleared 510(K)
- K922791LORACARBEF 30MCG DISK2Cleared 510(K)
- K921420AZITHROMYCIN, 15 MCG, SENSI DISC2Cleared 510(K)
- K921282MAXAQUIN2Cleared 510(K)
- K921193LOMEFLOXACIN, 10 MCG, SENSI DISC2Cleared 510(K)
- K920787TEMAFLOXCIN, 5MCG, SENSI DISC2Cleared 510(K)
- K920786LORACARBEF 30MCG, SENSI DISC2Cleared 510(K)
- K920473CEFPROZIL 30MCG, SENSI DISC2Cleared 510(K)
- K910506OFLOXACIN, 5 MCG SENSI-DISC2Cleared 510(K)
- K910412FLOXIN SUSCEPTIBILITY TEST DISKS2Cleared 510(K)
- K902082ZEFAZONE SUSCEPTIBILITY TEST DISKS2Cleared 510(K)
- K900344CEFIXIME 5 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K895679CEFMATZOLE 30 MCG SENSI DISC2Cleared 510(K)
- K892721IFA SENSIBAC CEFACLOR2Cleared 510(K)
- K895392ANTIMICROBIAL SUSCEPTIBILITY DISK2Cleared 510(K)
- K892728IFA SENSIBAC NORFLOXACIN2Cleared 510(K)
- K894829CEFIXIME 5 MCG SENSITIVITY DISKS2Cleared 510(K)
- K891772SPECTINOMYCIN 100 MCG SENSI-DISC2Cleared 510(K)
- K892713IFA SENSIBAC NALIDIXIC ACID2Cleared 510(K)
- K892735IFA SENSIBAC CEPHALOTIN2Cleared 510(K)
- K892733IFA SENSIBAC KANAMYCIN2Cleared 510(K)
- K892720IFA SENSIBAC GENTAMYCIN2Cleared 510(K)
- K892726IFA SENSIBAC PENICILLIN2Cleared 510(K)
- K892714IFA SENSIBAC NEOMYCIN2Cleared 510(K)
- K892718IFA SENSIBAC TETRACYCLINE2Cleared 510(K)
- K892719IFA SENSIBAC ERYTHROMYCIN2Cleared 510(K)
- K892722IFA SENSIBAC CINOXACIN2Cleared 510(K)
- K892723IFA SENSIBAC POLYMYXIN B2Cleared 510(K)
- K892724IFA SENSIBAC STREPTOMYCIN2Cleared 510(K)
- K892717IFA SENSIBAC BACITRACIN2Cleared 510(K)
- K892715IFA SENSIBAC NITROFURANTOIN2Cleared 510(K)
- K892725IFA SENSIBAC VANCOMYCIN2Cleared 510(K)
- K892727IFA SENSIBAC INIPENEM2Cleared 510(K)
- K892729IFA SENSIBAC TOBRAMYCIN2Cleared 510(K)
- K892730IFA SENSIBAC CHLROAMPHENICOL2Cleared 510(K)
- K893754CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS2Cleared 510(K)
- K890344GLOVES, PATIENT EXAMINATION2Cleared 510(K)
- K874425CIPROFLOXACIN 5 MCG SENSI-DISC2Cleared 510(K)
- K874256AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K873829CIPRO SENSITIVITY DISKS2Cleared 510(K)
- K873707CIPROFLOXACIN 5 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K872938AMPICIILLIN SULBACTAM 20MCG SENSITIVITY DISKS2Cleared 510(K)
- K872783AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC2Cleared 510(K)
- K871674TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D2Cleared 510(K)
- K870201DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG2Cleared 510(K)
- K870175BROTH ELUTION DISKS CLINDAMYCIN 10MCG2Cleared 510(K)
- K870870AZTREONAM 30 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K870348NORFLOXACIN 10 MCG SENSITIVITY DISKS2Cleared 510(K)
- K864848NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK2Cleared 510(K)
- K864756NORFLOXACIN 10 MCG SENSI DISC2Cleared 510(K)
- K870347AZTREONAM 30 MCG SENSITIVITY DISKS2Cleared 510(K)
- K865034AZTREONAM 30 MCG. SENSI-DISC2Cleared 510(K)
- K860895CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK2Cleared 510(K)
- K860153OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS2Cleared 510(K)
- K860536CEFOTETAN 30 MCG SENSI DISC2Cleared 510(K)
- K860527CEFOTETAN 30 MCG SENSITIVITY DISCS2Cleared 510(K)
- K855206CEFACLOR 30 MCG SENSITIVITY DISCS2Cleared 510(K)
- K855135CEFACLOR SENSI-DISC2Cleared 510(K)
- K852967GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK2Cleared 510(K)
- K852873CEFTAZIDIME 30MCG. SENI-DISC2Cleared 510(K)
- K852689GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK2Cleared 510(K)
- K852835CEFTAZIDIME 30 MCG SENSITVITY DISCS2Cleared 510(K)
- K851622TIMENTIN 85 MCG. SENSI-DISC2Cleared 510(K)
- K843725BIOGRAM2Cleared 510(K)
- K850957GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK2Cleared 510(K)
- K851228GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK2Cleared 510(K)
- K850606CEFTRIAXONE 30 MCG SENSITIVITY DISCS2Cleared 510(K)
- K850607AMDINOCILLIN 10 MCG SENSITIVITY DISCS2Cleared 510(K)
- K850358CEFTRIAXONE 30 MCG SENSI-DISC2Cleared 510(K)
- K850357AMDINOCILLIN 10 MCG SENSI-DISC2Cleared 510(K)
- K843172AUGMENTIN 30 MCG SENSITIVITY DISKS2Cleared 510(K)
- K842253AUGMENTIN 30 MCG SENSI DISC2Cleared 510(K)
- K842292CEFONICID 30 MCG SENSITIVITY DISCS2Cleared 510(K)
- K842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC2Cleared 510(K)
- K842252CEFONICID 30 MCG SENSI-DISC2Cleared 510(K)
- K833414AZLOCILLIN 75MCG. SENSITIVITY DISCS2Cleared 510(K)
- K833416CEFTIZOXIME 30 MCG SENSITIVITY DISCS2Cleared 510(K)
- K833415TICARCILLIN 75MCG. SENSITIVITY DISCS2Cleared 510(K)
- K833709CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK2Cleared 510(K)
- K832910DEFAZOLIN 30MCG. SENSITIVITY DISCS2Cleared 510(K)
- K832956CEFTIZOLIME 30 MCG SENSI-DISC2Cleared 510(K)
- K832909CEFUROXIME 30MCG. SENSITIVITY DISCS2Cleared 510(K)
- K832653CEFUROXIME 30MCG. SUSCEP DISK2Cleared 510(K)
- K832515CEFUROXIME 30 MCG SENSI-DISC2Cleared 510(K)
- K831179CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP2Cleared 510(K)
- K831153CEFAXOLIN 30 MCG SENSI-DISC2Cleared 510(K)
- K830956NETILMICIN 30MCG. SENSITIVITY DISCS2Cleared 510(K)
- K830732NETILMICIN 30 MCG SENSI DISC2Cleared 510(K)
- K830731NETILMICIN 30 MCG ANTIMICROBIAL DISK2Cleared 510(K)
- K823800AZLOCILLIN 75MCG SENSI-DISC2Cleared 510(K)
- K822809AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC2Cleared 510(K)
- K822832TICARCILLIN 75MCG. SENSI-DISC2Cleared 510(K)
- K822394TICARCILLIN SYSCEPT. DISKS2Cleared 510(K)
- K821262CEFOPERAZONE 75MCG SENSIT- DISCS2Cleared 510(K)
- K821264CEFOPERAZONE 75MCG SENSI-DISC2Cleared 510(K)
- K821229CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK2Cleared 510(K)
- K820019PIPERACILLIN 100MCG. ANTIMICROBIAL2Cleared 510(K)
- K812524PIPERACILLIN 100 MCG. SENSITIVITY DISCS2Cleared 510(K)
- K813441PIPERACILLIN 100 MCG. SENSI DISC2Cleared 510(K)
- K813387METRONIDAZOLE 80MCG. SENSI-DISC2Cleared 510(K)
- K812994MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK2Cleared 510(K)
- K812993MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK2Cleared 510(K)
- K812916MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D2Cleared 510(K)
- K812228MOXALACTAM 30 MCG. SENSITIVITY DISCS2Cleared 510(K)
- K812844MOXALACTAM 30MCG. SENSI-DISC2Cleared 510(K)
- K812783TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK2Cleared 510(K)
- K812571MEZLOCILLIN 75 MCG. SENSI-DISC2Cleared 510(K)
- K812525MEZLOCILLIN 75 MCG. SENSITIVITY DISCS2Cleared 510(K)
- K811377PARA-PAK2Cleared 510(K)
- K810564CEFOTAXIME 30 MCG. SENSI-DISC.2Cleared 510(K)
- K810546CEFOTAXIME 30 MCG. SENSITIVITY DISCS.2Cleared 510(K)
- K810427CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.2Cleared 510(K)
- K802194MINOCYCLINE 30MCG. SENSI DISC2Cleared 510(K)
- K802178MINOCYCLINE 30 MCG. SENSITIVITY DISCS2Cleared 510(K)
- K801648TRIMETHROPRIM 5MCG. SENSI DISC.2Cleared 510(K)
- K801474TRIMETHOPRIM 5MCG. SENSITIVITY DISCS2Cleared 510(K)
- K801473CINOXACIN 100 MCG. SENSITIVITY DISCS2Cleared 510(K)
- K800540CINOXACIN 100 MCG SENSI DISC2Cleared 510(K)
- N60242MS 2 AUTOMATED SYSTEM2PMA Approval
- K760701SULFACYTINE 0.25 MG.2Cleared 510(K)
- 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
- 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
HardyDisk AST Lefamulin 20µg (LMU20)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192326
- 510(k) Type
- Traditional
- Applicant
- Hardy Diagnostics
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/19/2019
- Days to Decision
- 23 days
- Submission Type
- Statement