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Microbiology

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

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RecordFirmDate
TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002 (K873060)Lakewood Biochemical Co., Inc.1987-08-24
DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST (K872493)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-08-24
CONTROLCHEK II(TM) (K873034)Petra Biomedical Products, Inc.1987-08-19
LATEX R. CONORII (K872129)Health Research, Inc.1987-08-19
VIVID CHLAMYDIA(TM) (K872148)Seragen Diagnostics, Inc.1987-08-19
GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT (K872325)Technology Management & Marketing, Inc.1987-08-12
IAFP UREA AGAR SLANT (K872691)I.A.F. Production, Inc.1987-08-11
IAFP SABOURAUD DEXTROSE AGAR (K872689)I.A.F. Production, Inc.1987-08-11
IAFP HEKTOEN ENTERIC AGAR (K872680)I.A.F. Production, Inc.1987-08-11
IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT (K872687)I.A.F. Production, Inc.1987-08-11
IAFP MANNITOL NACL (K872675)I.A.F. Production, Inc.1987-08-11
IAFP LOWENSTEIN JENSEN SLANT (K872685)I.A.F. Production, Inc.1987-08-11
IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD (K872688)I.A.F. Production, Inc.1987-08-11
IAFP P.E.A. AGAR W/5% SHEEP BLOOD (K872692)I.A.F. Production, Inc.1987-08-11
AMEBIASIS ELISA TEST KIT (K870318)Lmd Laboratories1987-08-11
IAFP C.D.C. ANAEROBIC AGAR W/5% SHEEP BLOOD (K872681)I.A.F. Production, Inc.1987-08-11
AFP MIDDLEBROOK 7H10 AGAR SLANT (K872676)I.A.F. Production, Inc.1987-08-11
IAFP MAC CONKEY AGAR (K872670)I.A.F. Production, Inc.1987-08-11
IAFP BILE ESCULIN AZIDE AGAR (K872672)I.A.F. Production, Inc.1987-08-11
IAFP BILE ESCULIN AGAR (K872683)I.A.F. Production, Inc.1987-08-11
IAFP S.S. AGAR (K872682)I.A.F. Production, Inc.1987-08-11
IAFP MUELLER HINTON AGAR (K872686)I.A.F. Production, Inc.1987-08-11
IAFP X.L.D. AGAR (K872669)I.A.F. Production, Inc.1987-08-11
IAFP CAMPYLOBACTER BLASER (K872684)I.A.F. Production, Inc.1987-08-11
GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT (K872326)Technology Management & Marketing, Inc.1987-08-11
IAFP COLUMBIA C.N.A. WITH 5% SHEEP BLOOD (K872674)I.A.F. Production, Inc.1987-08-11
I.A.F.P. C.D.C. ANAEROBIC SHEEP BLOOD AGAR W/P.E.A (K872673)I.A.F. Production, Inc.1987-08-11
SORBITOL MACCONKEY AGAR NO. 3 CM 813 (K872956)Oxoid U.S.A., Inc.1987-08-10
IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1 (K872678)I.A.F. Production, Inc.1987-08-07
IAFP T.S.A. W/5% SHEEP BLOOD (K872671)I.A.F. Production, Inc.1987-08-07
IAFP K.V. ANAEROBIC AGAR (K872665)I.A.F. Production, Inc.1987-08-07
IAFP K.V. ANAEROBIC AGAR W/5% SHEEP BLOOD (K872666)I.A.F. Production, Inc.1987-08-07
IAFP T.S.A. W/10% SHEEP BLOOD (K872668)I.A.F. Production, Inc.1987-08-07
IAFP T.S.A. (TRYPTIC SOY AGAR) (K872679)I.A.F. Production, Inc.1987-08-07
CAPTIA(R) SYPHILIS-M (K871548)Mercia Diagnostics , Ltd.1987-08-07
IAFP B.H.I. AGAR (K872677)I.A.F. Production, Inc.1987-08-07
IAFP BRAIN HEART INFUSION BROTH (K872667)I.A.F. Production, Inc.1987-08-07
CMV IGM MICROASSAY (K871832)Diamedix Corp.1987-08-07
RSR CARD TEST (K871252)Advanced Polymer Systems, Inc.1987-08-06
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. (K872903)Syva Co.1987-08-06
BBL(R) GASPAK CO2 POUCH(TM) (K872782)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-08-06
AMPICIILLIN SULBACTAM 20MCG SENSITIVITY DISKS (K872938)Difco Laboratories, Inc.1987-08-06
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE (K872082)Medical Diagnostic Technologies, Inc.1987-07-31
CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY (K871746)Mercia Diagnostics , Ltd.1987-07-31
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. (K871795)Gen-Probe, Inc.1987-07-30
TOXOPLASMA GONDII IGG ELISA (K871905)Electro-Nucleonics Laboratories, Inc.1987-07-30
AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC (K872783)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-07-27
FLUORTRAN - C(TM) (K872751)Para Scientific Co.1987-07-23
ENZYGNOST ANTI-CMV IGG TEST (K863488)Behring Diagnostics, Inc.1987-07-20
GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT (K870176)Genetic Systems Corp.1987-07-16
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II (K872507)Precision Dynamics Corp.1987-07-09
CORNING EASY WASH ELISA PLATES (K872273)Corning Medical & Scientific1987-07-07
MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT (K872252)Labsystems, Inc.1987-07-01
ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (K871229)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (K871234)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B (K871231)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (K871228)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS (K871230)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A (K871233)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (K871232)Microscan Div. Baxter Healthcare Corp.1987-06-26
EBV-CHECK(TM) TEST KIT (IGG) (K871373)Diagnostic Technology, Inc.1987-06-25
EBNA ACIF ASSAY KIT (K871298)Granbio, Inc.1987-06-25
MACCONKEY W/SORBITOL (K872188)Remel Co.1987-06-24
TRANSTUBE MW176 OT MD176 (K872213)Medical Wire & Equipment Co.1987-06-23
FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU (K872193)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-06-22
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT (K871831)Diagnostic Products Corp.1987-06-17
LYFO KWIK(TM) RUS KIT (K870731)Micro-Bio-Logics1987-06-17
ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT (K871620)Allelix, Inc.1987-06-17
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST (K872056)Boots-Celltech Diagnostics, Inc.1987-06-15
SENSIR SYSTEM (K870719)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-06-15
CIPRO (TM) DIAGNOSTIC POWDER (K872081)Miles Pharmaceuticals1987-06-15
MCBRIDE MEDIUM CM 819 (K872135)Oxoid U.S.A., Inc.1987-06-15
ORICULT-N CULTURE-PADDLE (K872058)Orion Corp.1987-06-10
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 (K870945)Oxoid U.S.A., Inc.1987-06-10
HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 (K870814)Microscan Div. Baxter Healthcare Corp.1987-06-04
ADENOLEX (R) LATEX AGGLUTINATION TEST (K864645)Orion Diagnostica, Inc.1987-06-04
MUCATE AGAR, SLANTS AND MUCATE BROTH (K872020)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-06-02
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT (K871860)Bio-Rad1987-05-29
MICROLAB AT (K871945)Hamilton Co.1987-05-29
LD PRESUMPTO QUAD (K871907)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-28
SYPHILIS SEROLOGICAL REAGENTS (K871226)New Horizons Diagnostics Co.1987-05-28
COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. (K870733)Enzo Biochem, Inc.1987-05-26
SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM (K871855)Gibco Laboratories Life Technologies, Inc.1987-05-26
GBNA MEDIUM (K871786)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-21
MRS AGAR AND MRS BROTH (K871702)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-20
ARYLSULFATASE BROTH (K871701)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-20
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D (K871674)Organon Teknika Corp.1987-05-15
CELL LIFTER (K871559)Corning Costar Corp.1987-05-15
ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) (K871709)Difco Laboratories, Inc.1987-05-15
ALKALINE PEPTONE WATER (K871640)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-13
TODD HEWITT W/CNA (LIM BROTH) (K871447)Remel Co.1987-05-13
THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE (K871105)New Horizons Diagnostics Co.1987-05-13
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST (K870602)Boots-Celltech Diagnostics, Inc.1987-05-08
CARIESCREEN LB (K871264)Apo Diagnostics, Inc.1987-05-07
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST (K870946)Serono Diagnostics, Inc.1987-04-29
MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 (K871541)Gibco Laboratories Life Technologies, Inc.1987-04-29
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (K864128)Diagnostic Technology, Inc.1987-04-29
CHLAMYDIAZYME DIAGNOSTIC KIT (K864842)Abbott Laboratories1987-04-29
DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG (K870201)Difco Laboratories, Inc.1987-04-29
CONTROLCHEK(TM) (K871445)Petra Biomedical Products, Inc.1987-04-29
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