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Microbiology

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

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RecordFirmDate
DISPENS-O-DISC(TM) NITROCEFIN (K941016)Difco Laboratories, Inc.1994-06-30
INFLUENZA B ANITGEN TEST (K942174)Neogenex1994-06-30
RSV ANTIGEN TEST (K942173)Neogenex1994-06-30
CMV EARLY ANTIGEN TEST (K942171)Neogenex1994-06-30
OPUS CMV-G (K933389)Pb Diagnostic Systems, Inc.1994-06-28
PASCO MIC AND MIC/ID PANELS (K935805)Pasco Laboratories, Inc.1994-06-13
EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (K933251)Virion (U.S.), Inc.1994-06-13
BACTICARD STREP (K936021)Remel Co.1994-05-20
FLEXSURE HP (K934863)Smithkline Diagnostics, Inc.1994-05-18
READER (K926248)Alamar Biosciences Laboratory, Inc.1994-05-17
PARAKIT (K941110)Hardy Diagnostics1994-05-17
CON-KIT (K941129)Medical Chemical Corp.1994-05-09
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY (K935809)Light Diagnostics1994-05-05
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY (K920301)Gen-Probe, Inc.1994-04-26
CLOSTRIDIUM DIFFICILE TOX-B TEST (K935296)Techlab, Inc.1994-04-26
EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY (K931520)Mrl Diagnostics1994-04-26
SPECIMEN TRANSPORT MEDIUM (K935618)Biowhittaker Molecular Applications, Inc.1994-04-21
SERIM PYLORITEK REAGENT STRIPS (K936034)Serim Research Corp.1994-04-21
QTEST(R) STREP (K935667)Becton Dickinson Advanced Diagnostics1994-04-21
RIM E.COLI 0157:H7 LATEX TEST (K933457)Remel Co.1994-04-20
UNKNOWN (K934774)Granbio, Inc.1994-04-20
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY (K920302)Gen-Probe, Inc.1994-04-06
DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT (K931922)Viratest Intl., Inc.1994-03-30
SENSI-CAL AMCO AEPA-1 (K935566)Radiometer America, Inc.1994-03-29
PATHODX CYTOMEGALOVIRUS (K934798)Diagnostic Products Corp.1994-03-25
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST (K924715)Gen-Probe, Inc.1994-03-11
FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST (K931557)Fuller Laboratories, Inc.1994-03-11
BIOMIC VIDEO PLATE READER (K932122)Giles Scientific, Inc.1994-03-01
PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC (K940359)Becton Dickinson Microbiology Systems1994-03-01
BACTICARD CANDIDA (K935124)Remel Co.1994-02-25
BACTICARD E. COLI (K934986)Remel Co.1994-02-23
CULTURESWAB TRANSPORT SYSTEM (K934894)Difco Laboratories, Inc.1994-02-22
STOOL TRANSPORT/PROCESSOR (K933370)Sage Products, Inc.1994-02-17
CRYPTO-LEX SYSTEM (K930418)Trinity Laboratories, Inc.1994-02-17
PARASAFE(R) FIXATIVE (K935316)Scientific Device Laboratory, Inc.1994-02-17
BACT/ALERT 120 (K934593)Organon Teknika Corp.1994-02-09
MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (K933122)Bioclinical Systems, Inc.1994-02-09
IMMUNOCARD ROTAVIRUS (K933587)Meridian Diagnostics, Inc.1994-02-03
MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (K933121)Bioclinical Systems, Inc.1994-02-03
PASCO MIC PANELS/ GENT & STREP SYNERGY (K934380)Pasco Laboratories, Inc.1994-01-27
PASCO MIC AND MIC/ID PANELS (K933709)Pasco Laboratories, Inc.1993-12-27
IDEIA(TM) ROTAVIRUS (K932384)Dako Diagnostics , Ltd.1993-12-27
PASCO MIC AND MIC/ID PANELS (K933746)Pasco Laboratories, Inc.1993-12-27
DRYSLIDE CEFIN (K930702)Difco Laboratories, Inc.1993-12-22
THAYER MARTIN, MODIFIED PILL POCKET (K934331)Hardy Diagnostics1993-12-21
TRANSGROW (K934330)Hardy Diagnostics1993-12-17
PYR TEST KIT (K931865)Hardy Diagnostics1993-12-15
MARTIN LEWIS WITH LINOCMYCIN (K931864)Hardy Diagnostics1993-12-15
STREP A NEGATIVE CONTROL (K924461)Pacific Biotech, Inc.1993-12-02
PARAPREP (K931849)Medastat Scientific Corp.1993-12-02
PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY (K933997)Alexon Biomedical, Inc.1993-11-22
REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK (K934100)Remel Co.1993-11-22
ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K933885)Alamar Biosciences, Inc.1993-11-16
PASCO MIC AND MIC/ID PANELS (K933849)Pasco Laboratories, Inc.1993-11-16
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS (K931443)Ortho Diagnostic Systems, Inc.1993-11-05
VISI-SPOT (K932752)J.S. Medical Assoc.1993-11-05
BACTICARD STREP (K933514)Remel Co.1993-10-28
REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK (K933657)Remel Co.1993-10-28
READAR (K930478)Alamar Biosciences, Inc.1993-10-22
SYNERGY SCREEN TEST, MODIFICATION (K921977)Baxter Healthcare Corp1993-10-12
MERIDIAN EBV-IGG TEST KIT (K925689)Fuller Laboratories, Inc.1993-10-12
MERIDIAN EBNA TEST KIT (K925690)Fuller Laboratories, Inc.1993-10-12
MERIDIAN EBV-EA TEST KIT (K925688)Fuller Laboratories, Inc.1993-10-12
TECHLAB 1-HOUR TOX-A-TEST (K931129)Techlab, Inc.1993-09-30
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT (K926090)Syva Co.1993-09-30
GC II AGAR WITH ISOVITALEX (K932882)Becton Dickinson Microbiology Systems1993-09-24
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (K926002)Alamar Biosciences Laboratory, Inc.1993-09-23
G C II AGAR WITH SENSIVITALEX (K932879)Becton Dickinson Microbiology Systems1993-09-21
READAR (K925951)Alamar Biosciences Laboratory, Inc.1993-08-31
PASCO MIC AND MIC/ID PANELS (K932917)Pasco Laboratories, Inc.1993-08-18
STAPH-A-LEX(TM) SYSTEM (K926173)Trinity Laboratories, Inc.1993-08-10
REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK (K933118)Remel Co.1993-08-10
UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG (K924689)United Biotech, Inc.1993-08-10
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA (K923903)Biomerieux Vitek, Inc.1993-08-09
DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K932082)Baxter Diagnostics, Inc.1993-07-20
ADAMS SCIENTIFIC SENSITIVITY DISCS (K932052)Adams Scientific, Inc.1993-07-19
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA (K930002)Ortho Diagnostic Systems, Inc.1993-07-16
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA (K930020)Ortho Diagnostic Systems, Inc.1993-07-16
READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS (K925859)Alamar Biosciences, Inc.1993-07-08
TURBIQUANT ASL (K915742)Behring Diagnostics, Inc.1993-06-28
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K930469)Alamar Biosciences Laboratory, Inc.1993-06-25
BIONOR TRANSPORTMEDIUM (K925450)Skoug Research Corp.1993-06-25
VIDAS TOXO COMPETITION (TXC) ASSAY (K931334)Biomerieux Vitek, Inc.1993-06-21
SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA (K923892)Smith River Biologicals1993-06-21
AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA (K931151)Microprobe Corp.1993-06-18
AFFIRM VPIII MICROBIAL IDENTIFICATION TEST (K931374)Microprobe Corp.1993-06-15
BECKMAN ANTI-STREPTOLYSIN O KIT (K926236)Beckman Instruments, Inc.1993-06-15
AMPLICOR CHLAMYDIA TRACHOMATIS TEST (K922906)Roche Molecular Systems, Inc.1993-06-15
ZINC PVA (K931383)Remel Co.1993-06-15
PARA-PAK PLUS (K931770)Meridian Diagnostics, Inc.1993-06-15
NINHYDRIN REAGENT (K931862)Hardy Diagnostics1993-06-15
REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK (K931799)Remel Co.1993-06-15
REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK (K931289)Remel Co.1993-06-02
REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK (K931290)Remel Co.1993-05-20
BBL CRYSTAL MRSA ID SYSTEM (K926294)Becton Dickinson Microbiology Systems1993-05-18
PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION (K931147)Alexon, Inc.1993-05-13
CATALASE REAGENT (K931414)Hardy Diagnostics1993-05-12
PASCO MIC AND MIC/ID PANELS (K931069)Pasco Laboratories, Inc.1993-05-12
OXYSTRIP (K930693)Hardy Diagnostics1993-05-12
VIDAS TOXO IG6 ASSAY (TX6) (K922737)Biomerieux Vitek, Inc.1993-05-11
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