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Ab Biodisk

FDA 510(k) & PMA Approved Devices — 64 products

Total Devices64
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K081325 ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/MLJWY2008-07-24 View
510(k) K052366 ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIAJWY2005-10-13 View
510(k) K042392 DAPTOMYCINJWY2004-12-13 View
510(k) K042390 ETEST FOR GEMIFLOXACINJWY2004-11-19 View
510(k) K040560 ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGNGZ2004-07-27 View
510(k) K021445 ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAEJWY2002-06-06 View
510(k) K020748 ETEST ERTAPENEMJWY2002-04-29 View
510(k) K010363 ETEST MEROPENEMJWY2001-04-09 View
510(k) K002139 ETEST LINEZOLIDLTX2000-11-08 View
510(k) K001547 ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIPJWY2000-08-07 View
510(k) K000596 ETEST GATIFLOXACINJWY2000-05-22 View
510(k) K000298 ETEST MOXIFLOXACINJWY2000-05-18 View
510(k) K992993 ETEST FOR QUINUPRISTIN/DALFOPRISTINLTX1999-11-16 View
510(k) K990722 ETEST FOR CEFUROXIMEJWY1999-04-22 View
510(k) K990685 TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)JWY1999-03-26 View
510(k) K990297 ETEST MINOCYCLINEJWY1999-03-22 View
510(k) K984581 SYSTEM U3 FOR CEPHALOTHINJWY1999-03-09 View
510(k) K984491 SYSTEM U3 FOR CEFUROXIMEJWY1999-03-09 View
510(k) K983890 SYSTEM U3JWY1999-02-18 View
510(k) K984144 SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACIDJWY1999-02-09 View
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