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

Decided510(k)Device and applicantCode
Jul 16, 2003K031545SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
Trek Diagnostic Systems, Inc.
JWY
Jun 13, 2003K031205PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Jun 12, 2003K031103PASCO MIC AND MIC/ID PANELS (ERTAPENEM)
Pasco Laboratories, Inc.
JWY
May 1, 2003K030933PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Oct 23, 2002K023202MICROSCAN SYNERGIES PLUS
Dade Microscan, Inc.
JWY
Oct 8, 2002K022656SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
Trek Diagnostic Systems, Inc.
JWY
Sep 25, 2002K022775SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
Trek Diagnostic Systems, Inc.
JWY
Sep 25, 2002K021997SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Trek Diagnostic Systems, Inc.
JWY
Jun 20, 2002K021627SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Trek Diagnostic Systems, Inc.
JWY
Jun 17, 2002K021181MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
Dade Microscan, Inc.
JWY
Jun 11, 2002K021018MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
Dade Microscan, Inc.
JWY
Jun 6, 2002K021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
Ab Biodisk, SE
JWY
Jun 6, 2002K021188MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
Dade Microscan, Inc.
JWY
Jun 6, 2002K021169MICROSTREP PLUS PANEL, AZITHROMYCIN
Dade Microscan, Inc.
JWY
Jun 6, 2002K021110MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
Dade Microscan, Inc.
JWY
Jun 3, 2002K020938MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
Dade Microscan, Inc.
JWY
May 15, 2002K020859CEFOTAXIME
Trek Diagnostic Systems, Inc.
JWY
May 9, 2002K021339HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
Trek Diagnostic Systems, Inc.
JWY
May 9, 2002K020820MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
Dade Behring, Inc.
JWY
May 9, 2002K020762GATIFLOXIN
Trek Diagnostic Systems, Inc.
JWY
May 8, 2002K020822MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
Dade Behring, Inc.
JWY
May 6, 2002K021037MICROSTREP PLUS PANEL WITH AMPICILLIN
Dade Behring, Inc.
JWY
May 6, 2002K020937MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
Dade Microscan, Inc.
JWY
Apr 30, 2002K020691MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
Dade Microscan, Inc.
JWY
Apr 30, 2002K020686MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE
Dade Microscan, Inc.
JWY
Apr 29, 2002K020748ETEST ERTAPENEM
Ab Biodisk, SE
JWY
Apr 26, 2002K020556MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
Dade Microscan, Inc.
JWY
Mar 26, 2002K014259SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Trek Diagnostic Systems, Inc.
JWY
Mar 22, 2002K020037DRIED GRAM NEGATIVE MIC/COMBO PANELS
Dade Microscan, Inc.
JWY
Mar 20, 2002K020331PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Mar 14, 2002K020162DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
Dade Behring, Inc.
JWY
Feb 19, 2002K014258SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Trek Diagnostic Systems, Inc.
JWY
Dec 21, 2001K013925SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
Trek Diagnostic Systems, Inc.
JWY
Dec 12, 2001K013580SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
Trek Diagnostic Systems, Inc.
JWY
Dec 12, 2001K013423MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
Dade Microscan, Inc.
JWY
Nov 26, 2001K013075SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Trek Diagnostic Systems, Inc.
JWY
Nov 2, 2001K012921SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Trek Diagnostic Systems, Inc.
JWY
Oct 30, 2001K012895HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
Trek Diagnostic Systems, Inc.
JWY
Sep 12, 2001K012565SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Trek Diagnostic Systems, Inc.
JWY
Aug 29, 2001K012151HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Trek Diagnostic Systems, Inc.
JWY
Aug 15, 2001K011803SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
Trek Diagnostic Systems, Inc.
JWY
Apr 9, 2001K010363ETEST MEROPENEM
Ab Biodisk, SE
JWY
Mar 6, 2001K004045SUSCEPTIBILITY TEST PANEL
Trek Diagnostic Systems, Inc.
JWY
Feb 27, 2001K003868SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
Trek Diagnostic Systems, Inc.
JWY
Feb 23, 2001K003834SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
Trek Diagnostic Systems, Inc.
JWY
Aug 10, 2000K001953PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Aug 9, 2000K001887MODIFICATION TO PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY
Aug 7, 2000K001547ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
Ab Biodisk, SE
JWY
Jul 24, 2000K001558SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
Trek Diagnostic Systems, Inc.
JWY
Jul 18, 2000K001612PASCO MIC AND MIC/ID PANELS
Pasco Laboratories, Inc.
JWY

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