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
Jul 18, 2000K001573SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
Trek Diagnostic Systems, Inc.
JWY
Jul 12, 2000K001516PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Jun 6, 2000K001036SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
Trek Diagnostic Systems, Inc.
JWY
May 23, 2000K001035SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
Trek Diagnostic Systems, Inc.
JWY
May 22, 2000K000596ETEST GATIFLOXACIN
Ab Biodisk, SE
JWY
May 18, 2000K000298ETEST MOXIFLOXACIN
Ab Biodisk, SE
JWY
Feb 18, 2000K983943MICROSTREP PLUS PANEL, LEVOFLOXACIN
Dade Microscan, Inc.
JWY
Jan 14, 2000K993679MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
Dade Microscan, Inc.
JWY
Jan 14, 2000K983953MICROSTREP PLUS PANEL, VANCOMYCIN
Dade Microscan, Inc.
JWY
Dec 9, 1999K983746MICROSTREP PLUS PANEL
Dade Microscan, Inc.
JWY
Sep 21, 1999K992296PASCO MIC AND MIC/ID PANELS, VANCOMYCIN
Pasco Laboratories, Inc.
JWY
Sep 16, 1999K992143MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)
Pasco Laboratories, Inc.
JWY
Sep 3, 1999K992108PASCO MIC AND MIC/ID PANELS (CEFEPIME)
Pasco Laboratories, Inc.
JWY
Aug 30, 1999K992059PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Aug 26, 1999K991925PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Jun 17, 1999K983922DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
Dade Microscan, Inc.
JWY
May 10, 1999K983408DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
Dade Microscan, Inc.
JWY
Apr 27, 1999K983711DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
Dade Microscan, Inc.
JWY
Apr 22, 1999K990722ETEST FOR CEFUROXIME
Ab Biodisk, SE
JWY
Mar 26, 1999K990685TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
Ab Biodisk, SE
JWY
Mar 22, 1999K990297ETEST MINOCYCLINE
Ab Biodisk, SE
JWY
Mar 9, 1999K984581SYSTEM U3 FOR CEPHALOTHIN
Ab Biodisk, SE
JWY
Mar 9, 1999K984491SYSTEM U3 FOR CEFUROXIME
Ab Biodisk, SE
JWY
Feb 18, 1999K983890SYSTEM U3
Ab Biodisk, SE
JWY
Feb 16, 1999K984489SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
Accumed Intl., Inc.
JWY
Feb 9, 1999K984144SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID
Ab Biodisk, SE
JWY
Feb 8, 1999K984087SYSTEM U3 FOR AMPICILLIN
Ab Biodisk, SE
JWY
Jan 5, 1999K983565SYSTEM U3 FOR NITROFURANTOIN
Ab Biodisk, SE
JWY
Dec 30, 1998K983571SYSTEM U3 FOR TETRACYCLINE
Ab Biodisk, SE
JWY
Dec 23, 1998K983486SYSTEM U3 FOR NORFLOXACIN
Ab Biodisk, SE
JWY
Nov 25, 1998K983301SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
Accumed Intl., Inc.
JWY
Nov 25, 1998K983259SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
Ab Biodisk, SE
JWY
Nov 20, 1998K983252SYSTEM U3 FOR GENTAMICIN
Ab Biodisk North America, Inc.
JWY
Oct 2, 1998K983027TRIMETHOPRIM/SULPHAMETHOXAZOLE
Ab Biodisk, SE
JWY
Sep 30, 1998K982868ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE
Ab Biodisk, SE
JWY
Sep 3, 1998K981639SYSTEM U3 FOR CIPROFLOXACIN
Ab Biodisk, SE
JWY
Jul 6, 1998K980877ETEST CEFDINIR
Ab Biodisk, SE
JWY
Jun 15, 1998K980335ETEST BENZYLPENICILLIN
Ab Biodisk, SE
JWY
Jun 9, 1998K981137ETEST CEFOTAXIME
Ab Biodisk, SE
JWY
Jun 9, 1998K981136ETEST FOSFOMYCIN
Ab Biodisk, SE
JWY
Jun 9, 1998K981135ETEST BENZYLPENICILLIN
Ab Biodisk, SE
JWY
Jun 5, 1998K981138ETEST CIPROFLOXACIN
Ab Biodisk, SE
JWY
Jun 1, 1998K981139ETEST CEFTRIAXONE
Ab Biodisk, SE
JWY
May 29, 1998K980348ETEST VANCOMYCIN
Ab Biodisk, SE
JWY
May 29, 1998K980342ETEST CHLORAMPHENICAL
Ab Biodisk, SE
JWY
May 28, 1998K981134ETEST TETRACYCLINE
Ab Biodisk, SE
JWY
May 28, 1998K980338ETEST OFLOXACIN
Ab Biodisk, SE
JWY
May 27, 1998K980347ETEST TETRACYCLINE
Ab Biodisk, SE
JWY
May 27, 1998K980345ETEST CEFTRIAXONE
Ab Biodisk, SE
JWY
May 18, 1998K980773ETEST GREPAFLOXACIN
Ab Biodisk, SE
JWY

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