ClearanceBrief
Panels › Microbiology › Product code JWY · Class 2

Manual Antimicrobial Susceptibility Test Systems

Regulation 866.1640

2510(k)s in 12 months (441 all time)
0recalls in 12 months (78 all time)
77recalls that name a 510(k)
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Top companies in JWY

Company510(k)sRecalls
Ab Biomerieux1549
Ab Biodisk610
Trek Diagnostic Systems510
Thermo Fisher Scientific470
Pasco Laboratories, Inc.390
Liofilchem s.r.l.350
Bd Becton Dickinson Vacutainer Systems Preanalytic320
Dade Microscan, Inc.260
Alamar Biosciences Laboratory, Inc.220
Beckman Coulter, Inc.410
Decided510(k)Device and applicantCode
May 13, 1998K980603ETEST TROVAFLOXACIN
Ab Biodisk, SE
JWY
Feb 12, 1998K974362PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Nov 5, 1997K973695PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Sep 8, 1997K972688MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN
Dade Microscan, Inc.
JWY
Sep 8, 1997K972524DRIED GRAM-POSITIVE MIC/COMBO PANELS
Dade Intl., Inc.
JWY
Aug 20, 1997K972567PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Aug 15, 1997K971951PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Aug 1, 1997K972180DRIED GRAM-NEGATIVE MIC/COMBO PANELS
Dade Microscan, Inc.
JWY
Jul 14, 1997K971697ETEST FOR LEVOFLOXACIN
Ab Biodisk, SE
JWY
Jun 30, 1997K971694ETEST FOR CEFTAZIDIME
Ab Biodisk, SE
JWY
May 30, 1997K971376DRIED GRAM-NEGATIVE MIC/COMBO PANELS
Dade Microscan, Inc.
JWY
May 2, 1997K970676DRIED GRAM-NEGATIVE MIC/COMBO PANELS
Dade Intl., Inc.
JWY
May 1, 1997K970473ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
Ab Biodisk, SE
JWY
May 1, 1997K970210AMIKACIN
Ab Biodisk, SE
JWY
May 1, 1997K964236(MODIFIED) ETEST PACKAGE INSERT
Ab Biodisk, SE
JWY
Apr 25, 1997K970820ETEST SPARFLOXACIN
Ab Biodisk, SE
JWY
Mar 19, 1997K965190SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
Accumed Intl., Inc.
JWY
Dec 18, 1996K964203PIPERACILLIN/TAZOBACTAM 4
Ab Biodisk, SE
JWY
Dec 18, 1996K963641STREPTOCOCCUS MIC PANEL
Dade Microscan, Inc.
JWY
Oct 24, 1996K963107ETEST FOR CEFEPIME
Ab Biodisk, SE
JWY
Oct 8, 1996K960991ETEST SUBMISSION FOR AMOXICILLIN
Ab Biodisk, SE
JWY
Sep 30, 1996K962867SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
Sensititre Alamar
JWY
Aug 30, 1996K962794ETEST FOR AZTREONAM
Ab Biodisk, SE
JWY
Jul 5, 1996K961519ETEST SUBMISSION FOR AZITHROMYCIN
Ab Biodisk, SE
JWY
Jul 5, 1996K961517ETEST SUBMISSION FOR CEFOTETAN
Ab Biodisk, SE
JWY
May 20, 1996K960990ETEST SUBMISSION FOR VANCOMYCIN
Ab Biodisk, SE
JWY
May 20, 1996K960989ETEST SUBMISSION FOR IMIPENEM
Ab Biodisk, SE
JWY
Mar 27, 1996K960235SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
Accumed Intl., Inc.
JWY
Mar 11, 1996K960220SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
Sensititre , Ltd.
JWY
Feb 23, 1996K955910DRIED GRAM-NEGATIVE MIC/COMBO PANELS
Dade Microscan, Inc.
JWY
Feb 22, 1996K955920THE E TEST CEFTIZOXIME
Ab Biodisk, SE
JWY
Dec 12, 1995K954319AMOXICILLIN/CLAVULANIC ACID 2/1
Ab Biodisk, SE
JWY
Oct 7, 1995K953422FOX FASTIDIOUS TEST PANELS
Micro-Media Systems, Inc.
JWY
Oct 7, 1995K951241HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
Radiometer America, Inc.
JWY
Oct 7, 1995K951240JUSTONE
Radiometer America, Inc.
JWY
Aug 15, 1995K953223PIPERACILIN TAZOBACTAM 4 UG
Ab Biodisk, SE
JWY
Jul 18, 1995K934458DRIED GRAM-POSITIVE MIC/COMBO PANELS
Baxter Diagnostics, Inc.
JWY
Jul 13, 1995K936305SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
Radiometer America, Inc.
JWY
Jul 7, 1995K951879TICARCILLIN/CLAVULANIC ACID 2
Ab Biodisk, SE
JWY
Jun 13, 1995K951539ENTEROCOCCUS SCREENING MEDIUM
Becton Dickinson Microbiology Systems
JWY
May 2, 1995K946364E TEST FOR OFLOXACIN
Ab Biodisk, SE
JWY
Apr 25, 1995K950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
Baxter Diagnostics, Inc.
JWY
Apr 14, 1995K950328AMOXICILLIN/CLAVULANIC ACID 2/1
Ab Biodisk North America, Inc., SE
JWY
Mar 23, 1995K950123SCEPTOR SYSTEM PANELS
Becton Dickinson Microbiology Systems
JWY
Mar 17, 1995K945433ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS
Ab Biodisk, SE
JWY
Feb 24, 1995K944753SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
Radiometer America, Inc.
JWY
Feb 17, 1995K943756MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE
Alamar Biosciences, Inc.
JWY
Feb 16, 1995K945997MODIFIED FOX EXTRA GRAM POSITIVE
Micro-Media Systems, Inc.
JWY
Feb 16, 1995K935485FAS FASTIDIOUS MIC PANEL
Microtech Medical Systems, Inc.
JWY
Feb 8, 1995K940917LORACARBEF GRAM-NAGATIVE PANELS
Baxter Diagnostics, Inc.
JWY

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