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Microbiology

6,936 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
MYCOPLASMA IGM ELISA TEST SYSTEM (K971503)Zeus Scientific, Inc.1997-08-20
PASCO MIC AND MIC/ID PANELS (K971951)Pasco Laboratories, Inc.1997-08-15
TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971632)Oxoid , Ltd.1997-08-13
BACTEC MYCO/F-SPUTA CULTURE VIALS (K972758)Becton Dickinson Microbiology Systems1997-08-08
ROTAVIRUS EIA (K964424)Trinity Biotech, Inc.1997-08-08
DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K972180)Dade Microscan, Inc.1997-08-01
MODIFICATION OF EST CULTURE SYSTEM II - MYCO (K972756)Accumed Intl., Inc.1997-08-01
FOSFOMYCIN, 200 MG, SENSI-DISC (K972098)Becton Dickinson Microbiology Systems1997-07-28
STREP A OIA MAX (K962060)Biostar, Inc.1997-07-23
TOX A/B TEST (K971182)Techlab, Inc.1997-07-22
QUANTA LITE RUBEOLA (MEASLES) IGG (K971620)Inova Diagnostics, Inc.1997-07-22
ETEST FOR LEVOFLOXACIN (K971697)Ab Biodisk1997-07-14
MYCOPLASMA IGG ELISA TEST SYSTEM (K971393)Immunoprobe, Inc.1997-07-14
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS (K972146)Consolidated Technologies, Inc.1997-07-08
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST (K971349)Princeton BioMeditech Corp.1997-07-07
AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971635)Oxoid , Ltd.1997-07-03
PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971633)Oxoid , Ltd.1997-07-03
CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971631)Oxoid , Ltd.1997-07-03
HSV-1 ANTIGEN CONTROL SLIDES (K964874)Viral Antigens, Inc.1997-07-01
HSV-2 ANTIGEN CONTROL SLIDES (K971101)Viral Antigens, Inc.1997-07-01
ETEST FOR CEFTAZIDIME (K971694)Ab Biodisk1997-06-30
PYLORISET EIA-G (68926) (K971537)Orion Diagnostica, Div. Orion Corp.1997-06-27
INDICARD TEST (K964015)Litmus Concepts, Inc.1997-06-19
LEGIONELLA ELISA TEST SYSTEM (K970149)Zeus Scientific, Inc.1997-06-18
MYCOPLASMA IGG ELISA TEST SYSTEM (K970150)Zeus Scientific, Inc.1997-06-16
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST (K964507)Roche Molecular Systems, Inc.1997-06-13
DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K971376)Dade Microscan, Inc.1997-05-30
VIDAS ROTAVIRUS ASSAY (K965092)Biomerieux Vitek, Inc.1997-05-05
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) (K963054)Genbio1997-05-05
DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K970676)Dade Intl., Inc.1997-05-02
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (K963055)Genbio1997-05-02
ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE (K970473)Ab Biodisk1997-05-01
INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY (K963289)Incstar Corp.1997-05-01
(MODIFIED) ETEST PACKAGE INSERT (K964236)Ab Biodisk1997-05-01
AMIKACIN (K970210)Ab Biodisk1997-05-01
ETEST SPARFLOXACIN (K970820)Ab Biodisk1997-04-25
PYR SWAB (K970832)Remel, Inc.1997-04-24
COPALIS TORC TOTAL ANTIBODY ASSAY (K970931)Sienna Biotech, Inc.1997-04-24
IMMULITE TOXOPLASMA QUANTITATIVE IGG (K962936)Diagnostic Products Corp.1997-04-24
GRAM SWAB (K970834)Remel, Inc.1997-04-17
DISPENS-O-DISC SPARFLOXACIN (K971211)Difco Laboratories, Inc.1997-04-14
DISPENS-O-DISC (TM) LEVOFLOXACIN (K971120)Difco Laboratories, Inc.1997-04-14
VIDAS C. DIFFICILE TOXIN A II ASSAY (K964887)Biomerieux Vitek, Inc.1997-04-08
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK (K970830)Remel, Inc.1997-04-02
INDOLE SWAB (K970833)Remel, Inc.1997-04-02
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK (K970831)Remel, Inc.1997-04-02
IMMULITE RUBELLA IGG (K963613)Diagnostic Products Corp.1997-04-02
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (K965131)Wampole Laboratories1997-03-26
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (K965129)Wampole Laboratories1997-03-26
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) (K954301)Abbott Laboratories1997-03-24
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION) (K970597)Medical Packaging Corp.1997-03-24
TOXO IGG ELISA TEST (K962343)Gull Laboratories, Inc.1997-03-24
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE (K965190)Accumed Intl., Inc.1997-03-19
CMV ANTIGEN CONTROL SLIDES (K964875)Viral Antigens, Inc.1997-03-18
VZV ANTIGEN CONTROL SLIDES (K964872)Viral Antigens, Inc.1997-03-18
RSV ANTIGEN CONTROL SLIDES (K964870)Viral Antigens, Inc.1997-03-18
SPARFLOZACIN, 5 MCG, SENSI-DISC (K970385)Becton Dickinson Microbiology Systems1997-03-10
LEVOFLOXACIN, 5MCG, SENSI-DISC (K970212)Becton Dickinson Microbiology Systems1997-03-06
KENLOR H. PYLORI CONTROL SERUM (K964014)Kenlor Industries, Inc.1997-03-03
LEGIONELLA IGG/IGM ELISA TEST SYSTEM (K963318)Armkel, LLC1997-03-03
CHLAMYDIA IGG ELISA TEST SYSTEM (K962558)Armkel, LLC1997-02-24
HEMAGEN CMV IGG KIT (K944438)Hemagen Diagnostics, Inc.1997-02-20
ACCUMETER H. PYLORI TEST (K965099)Chemtrak, Inc.1997-02-20
CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964492)Unipath , Ltd.1997-02-07
CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964495)Unipath , Ltd.1997-02-07
REMEL STAPH LATEX KIT (K964315)Remel, L.P.1997-02-07
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964491)Unipath , Ltd.1997-02-07
AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964490)Unipath , Ltd.1997-02-07
IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964487)Unipath , Ltd.1997-02-07
CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964489)Unipath , Ltd.1997-02-07
CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC (K964496)Unipath , Ltd.1997-02-06
OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964493)Unipath , Ltd.1997-02-06
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (K970009)Microbiologics, Inc.1997-02-06
SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964501)Unipath , Ltd.1997-02-06
CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964512)Unipath , Ltd.1997-02-06
CETIBUTEN, 30MCG, SENSI-DISC (K965159)Becton Dickinson Microbiology Systems1997-02-04
HERPES GROUP IGG ELISA TEST SYSTEM (K963645)Armkel, LLC1997-02-04
RAPID GRAM-POSITIVE ID SYSTEM (K961730)Becton Dickinson Microbiology Systems1997-02-04
ACCESS CHLAMYDIA ASSAY (K960850)Bio-Rad Laboratories, Inc.1997-02-04
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY (K964864)Alexon Biomedical, Inc.1997-02-04
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM (K961968)Bd Becton Dickinson Vacutainer Systems Preanalytic1997-02-04
H.PYLORI CONTROLS (K964675)Pyramid Biological Corp.1997-01-27
A.C.T. I (K965149)Remel Co.1997-01-22
A.C.T. II (K965152)Remel Co.1997-01-22
A.C.T. III (K965151)Remel Co.1997-01-22
SERAQUEST HSV IGG (K963282)Quest Intl., Inc.1997-01-22
A.C.T. IV (K965150)Remel Co.1997-01-22
IMMUNOCARD H. PYLORI (K961508)Meridian Diagnostics, Inc.1997-01-21
BHI W/VANCOMYCIN AGAR (K964560)Hardy Diagnostics1997-01-15
IMAGEN RESPIRATORY SCREEN (K962037)Dako Diagnostics , Ltd.1996-12-26
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA (K964637)Medical Packaging Corp.1996-12-24
RUBASCAN CARD TEST (K952721)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-12-20
STREPTOCOCCUS MIC PANEL (K963641)Dade Microscan, Inc.1996-12-18
PIPERACILLIN/TAZOBACTAM 4 (K964203)Ab Biodisk1996-12-18
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) (K963296)Incstar Corp.1996-12-16
STREPTOLEX-STAT (K962296)Unipath , Ltd.1996-12-16
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) (K963297)Incstar Corp.1996-12-16
REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK (K964421)Remel, L.P.1996-12-06
GIARDIA CELISA (K963135)Techlab, Inc.1996-11-29
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT (K962217)Gen-Probe, Inc.1996-11-27
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