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Microbiology

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

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RecordFirmDate
MULTIPLE (IZON DBS & URINE COLLECTION KIT) (K950257)Izon Business Products, Inc.1995-04-14
AMOXICILLIN/CLAVULANIC ACID 2/1 (K950328)Ab Biodisk North America, Inc.1995-04-14
PYLORISET DRY (K942974)Orion Diagnostica, Div. Orion Corp.1995-04-05
PINWORM EGG COLLECTOR (K950096)Evergreen Industries, Inc.1995-04-05
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (K945911)Bioclinical Systems, Inc.1995-04-04
SCEPTOR SYSTEM PANELS (K950123)Becton Dickinson Microbiology Systems1995-03-23
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (K950221)Izon Business Products, Inc.1995-03-21
MULTIPLE (IZON URINE COLLECTION KIT) (K950246)Izon Business Products, Inc.1995-03-21
ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS (K945433)Ab Biodisk1995-03-17
MYCOAKT M. AVIUM CULTURE ID KIT (K943049)Dynagen, Inc.1995-03-13
MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT (K943051)Dynagen, Inc.1995-03-13
MYCOAKT M KANSASII CULTURE ID KIT (K943050)Dynagen, Inc.1995-03-13
COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM (K946288)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM (K946286)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM STUARTS MEDIUM (K946285)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM (K946283)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (K946284)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (K946287)Copan Diagnostics, Inc.1995-03-10
ENTAMOEBA TEST (K944791)Techlab, Inc.1995-03-09
SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA (K945839)Sa Scientific, Inc.1995-03-07
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K945235)Baxter Diagnostics, Inc.1995-03-07
BBLCRYSTAL ANAEROBE ID SYSTEM (K944528)Becton Dickinson Microbiology Systems1995-03-07
PREMIER(TM) H. PYLORY (K945558)Meridian Diagnostics, Inc.1995-03-03
SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP (K944753)Radiometer America, Inc.1995-02-24
BACT/ALERT FAN CULTURE BOTTLE (K944594)Organon Teknika Corp.1995-02-17
MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE (K943756)Alamar Biosciences, Inc.1995-02-17
MODIFIED FOX EXTRA GRAM POSITIVE (K945997)Micro-Media Systems, Inc.1995-02-16
DRIED GRAM-NEGATIVE CEFPODOXIME (K941030)Baxter Diagnostics, Inc.1995-02-16
KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM (K944847)Starplex Scientific, Inc.1995-02-16
FAS FASTIDIOUS MIC PANEL (K935485)Microtech Medical Systems, Inc.1995-02-16
QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS) (K945080)Quidel Corp.1995-02-10
LORACARBEF GRAM-NAGATIVE PANELS (K940917)Baxter Diagnostics, Inc.1995-02-08
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX (K941459)Baxter Diagnostics, Inc.1995-02-03
GCII AGAR WITH ISOVITALX(R) ENRICHMENT (K945569)Becton Dickinson Microbiology Systems1995-02-02
DRIED GRAM NEGATIVE/CEFMETAZOLE (K941317)Baxter Diagnostics, Inc.1995-01-31
BBL CRYSTAL MRSA ID SYSTEM (K941997)Becton Dickinson Microbiology Systems1995-01-27
RAPID YEAST PLUS SYSTEM (K943621)Innovative Diagnostic Systems, Inc.1995-01-27
PROLEX (STREPTOCCAL GROUPING LATEX KIT) (K934383)Pro-Lab, Inc.1995-01-27
PASCO MIC AND MIC/ID PANELS (K946126)Pasco Laboratories, Inc.1995-01-17
IMAGEN (K943557)Dako Diagnostics , Ltd.1995-01-09
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE (K942267)Baxter Diagnostics, Inc.1995-01-09
MICRODILUTION/LORACARBEF PANELS (K942089)Baxter Diagnostics, Inc.1995-01-09
ABBOTT CHAGAS ANTIBODY EIA (K933716)Abbott Laboratories1994-12-19
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (K943317)Diagnostic Products Corp.1994-12-19
DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. (K944275)Difco Laboratories, Inc.1994-12-19
IMX RUBELLA IGM ANTIBODY ASSAY (K931059)Abbott Laboratories1994-12-19
BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM (K944319)Giles Scientific, Inc.1994-12-15
VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT (K942743)Viro Research, Inc.1994-12-15
E.COLI 0157 LATEX TEST (K944421)Pro-Lab Diagnostics1994-12-15
ALAMAR ANTIBIOTIC SUSCEPTIBILITY (K941425)Alamar Biosciences Laboratory, Inc.1994-12-15
DIARLEX ROTA-ADENO (K942286)Orion Diagnostica, Inc.1994-12-14
IMMUNOCARD H. PYLORI (K941560)Meridian Diagnostics, Inc.1994-12-08
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K943510)Baxter Diagnostics, Inc.1994-12-02
KULTSURE STARSWAB(M240), MODIFICATION (K943499)Ncs Diagnostics, Inc.1994-11-30
KULTSURE STARSWAB (M210), MODIFICATION (K943498)Ncs Diagnostics, Inc.1994-11-30
VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT (K933575)Symex Corp.1994-11-28
REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST (K942093)Medical Diagnostic Technologies, Inc.1994-11-28
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K944651)Baxter Diagnostics, Inc.1994-11-18
PROSPECT CRYPTOSPORIDIUM RAPID ASSAY (K936191)Alexon Biomedical, Inc.1994-11-17
ETEST FOR AMPICILLIN/SULBACTAM 2/1 (K935519)Ab Biodisk North America, Inc.1994-11-04
SAS SALMONELLA H D ANTISERUM (K943400)Sa Scientific, Inc.1994-11-02
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR (K940979)Gen-Probe, Inc.1994-10-31
GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS (K943407)Becton Dickinson Microbiology Systems1994-10-27
MICROSPORIDIUM CONTROL SET (K943228)Meridian Diagnostics, Inc.1994-10-27
MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5) (K941579)Microtest1994-10-21
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION (K944723)Alamar Biosciences, Inc.1994-10-21
DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL (K934323)Baxter Diagnostics, Inc.1994-10-19
PASCO MIC AND MIC/ID PANELS (K944517)Pasco Laboratories, Inc.1994-10-19
MUMPS STAT (K925209)Biowhittaker Molecular Applications, Inc.1994-10-14
BRAIN HEART INFUSION AGAR (K944554)Carr-Scarborough Microbiologicals, Inc.1994-10-04
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY (K935393)Bio-Rad Laboratories, Inc.1994-09-20
BINAX LEGIONELLA URINARY ANTIGEN EIA (K934965)Binax, Inc.1994-09-20
PROSPECT MICROPLATE ASSAY (K934493)Alexon, Inc.1994-09-20
IMMUNOCARD MYCOPLASMA (K934550)Meridian Diagnostics, Inc.1994-09-20
BHI AGAR WITH VANCOMYCIN (K941444)Remel Co.1994-09-19
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG (K935975)Remel, Inc.1994-09-19
SYNERGY QUAD (K941443)Remel Co.1994-09-19
SWABZYME OXIDASE (K934130)E-Y Laboratories, Inc.1994-09-14
B-LACTAMASE REAGENT TUBES (K940161)E-Y Laboratories, Inc.1994-09-09
GONOCHEK-II, MODIFICATION (K934125)E-Y Laboratories, Inc.1994-09-09
PROSPECT GIARDIA (K942098)Alexon, Inc.1994-09-09
CULTURIA MACCONKEY-MUG (K934759)Clinical Convenience Products, Inc.1994-09-09
GONOCHEK II REAGENT TUBES (K940162)E-Y Laboratories, Inc.1994-09-09
BACT/ALERT FAN AEROBIC CULTURE BOTTLE (K935711)Organon Teknika Corp.1994-08-30
STREP-A-CHEK(TM) REAGENT STRIPS (K940020)E-Y Laboratories, Inc.1994-08-26
EY-20 REAGENT TUBES (K940124)E-Y Laboratories, Inc.1994-08-26
STREP-A-CHEK (K934129)E-Y Laboratories, Inc.1994-08-26
MUELLER HINTON AGAR W/OXACILLIN (K941985)Carr-Scarborough Microbiologicals, Inc.1994-08-24
CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED (K936078)Medical Packaging Corp.1994-08-16
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM (K932337)Medical Packaging Corp.1994-08-16
FLEXTRANS (K935987)Baxter Diagnostics, Inc.1994-08-15
STREP-SURE A/E (K941111)Clinical Standards Laboratories, Inc.1994-08-02
VIDAS CMV IGM ASSAY (K933549)Biomerieux Vitek, Inc.1994-08-02
STAPHYTECT-OD (K940557)Unipath , Ltd.1994-07-28
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 (K932482)Medix Biotech, Inc.1994-07-18
QUICKVUE IN-LINE ONE-STEP STREP A TEST (K934484)Quidel Corp.1994-07-18
CHLAMYDIA TRACHOMATIS ANTIGEN TEST (K941714)Neogenex1994-07-18
BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST (K925355)Princeton Biomedix1994-07-12
INFLUENZA A ANTIGEN TEST (K942172)Neogenex1994-07-06
STREP B OIA (K936112)Biostar, Inc.1994-07-06
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