FDA 510(k) Applications Submitted by AB BIODISK

FDA 510(k) Number Submission Date Device Name Applicant
K081325 05/12/2008 ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML AB BIODISK
K960990 03/11/1996 ETEST SUBMISSION FOR VANCOMYCIN AB BIODISK
K960991 03/11/1996 ETEST SUBMISSION FOR AMOXICILLIN AB BIODISK
K961519 04/22/1996 ETEST SUBMISSION FOR AZITHROMYCIN AB BIODISK
K963107 08/12/1996 ETEST FOR CEFEPIME AB BIODISK
K002139 07/17/2000 ETEST LINEZOLID AB BIODISK
K970210 01/21/1997 AMIKACIN AB BIODISK
K980348 01/28/1998 ETEST VANCOMYCIN AB BIODISK
K980347 01/28/1998 ETEST TETRACYCLINE AB BIODISK
K980342 01/28/1998 ETEST CHLORAMPHENICAL AB BIODISK
K980335 01/28/1998 ETEST BENZYLPENICILLIN AB BIODISK
K980338 01/28/1998 ETEST OFLOXACIN AB BIODISK
K980345 01/29/1998 ETEST CEFTRIAXONE AB BIODISK
K990297 01/29/1999 ETEST MINOCYCLINE AB BIODISK
K000298 01/31/2000 ETEST MOXIFLOXACIN AB BIODISK
K970473 02/07/1997 ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE AB BIODISK
K010363 02/07/2001 ETEST MEROPENEM AB BIODISK
K980603 02/17/1998 ETEST TROVAFLOXACIN AB BIODISK
K000596 02/22/2000 ETEST GATIFLOXACIN AB BIODISK
K980773 03/02/1998 ETEST GREPAFLOXACIN AB BIODISK
K990685 03/03/1999 TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) AB BIODISK
K040560 03/03/2004 ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING AB BIODISK
K990722 03/05/1999 ETEST FOR CEFUROXIME AB BIODISK
K970820 03/06/1997 ETEST SPARFLOXACIN AB BIODISK
K020748 03/07/2002 ETEST ERTAPENEM AB BIODISK
K980877 03/09/1998 ETEST CEFDINIR AB BIODISK
K960989 03/11/1996 ETEST SUBMISSION FOR IMIPENEM AB BIODISK
K981137 03/30/1998 ETEST CEFOTAXIME AB BIODISK
K981138 03/30/1998 ETEST CIPROFLOXACIN AB BIODISK
K981134 03/30/1998 ETEST TETRACYCLINE AB BIODISK
K981139 03/30/1998 ETEST CEFTRIAXONE AB BIODISK
K981135 03/30/1998 ETEST BENZYLPENICILLIN AB BIODISK
K981136 03/30/1998 ETEST FOSFOMYCIN AB BIODISK
K961517 04/22/1996 ETEST SUBMISSION FOR CEFOTETAN AB BIODISK
K021445 05/06/2002 ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE AB BIODISK
K971694 05/07/1997 ETEST FOR CEFTAZIDIME AB BIODISK
K971697 05/08/1997 ETEST FOR LEVOFLOXACIN AB BIODISK
K981639 05/08/1998 SYSTEM U3 FOR CIPROFLOXACIN AB BIODISK
K001547 05/18/2000 ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP AB BIODISK
K962794 07/17/1996 ETEST FOR AZTREONAM AB BIODISK
K982868 08/14/1998 ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE AB BIODISK
K052366 08/29/2005 ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA AB BIODISK
K983027 08/31/1998 TRIMETHOPRIM/SULPHAMETHOXAZOLE AB BIODISK
K042392 09/02/2004 DAPTOMYCIN AB BIODISK
K042390 09/02/2004 ETEST FOR GEMIFLOXACIN AB BIODISK
K992993 09/07/1999 ETEST FOR QUINUPRISTIN/DALFOPRISTIN AB BIODISK
K983259 09/16/1998 SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE AB BIODISK
K964203 10/02/1996 PIPERACILLIN/TAZOBACTAM 4 AB BIODISK
K983486 10/05/1998 SYSTEM U3 FOR NORFLOXACIN AB BIODISK
K983565 10/13/1998 SYSTEM U3 FOR NITROFURANTOIN AB BIODISK
K983571 10/13/1998 SYSTEM U3 FOR TETRACYCLINE AB BIODISK
K964236 10/18/1996 (MODIFIED) ETEST PACKAGE INSERT AB BIODISK
K955920 11/01/1995 THE E TEST CEFTIZOXIME AB BIODISK
K984087 11/16/1998 SYSTEM U3 FOR AMPICILLIN AB BIODISK
K984144 11/18/1998 SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID AB BIODISK
K984491 12/17/1998 SYSTEM U3 FOR CEFUROXIME AB BIODISK
K984581 12/23/1998 SYSTEM U3 FOR CEPHALOTHIN AB BIODISK
K983890 11/02/1998 SYSTEM U3 AB BIODISK


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