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Microbiology

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

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RecordFirmDate
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST (K852779)Syva Co.1985-09-16
PRECEPT TM MOXALACTAM (K853689)Austin Biological Laboratories1985-09-13
PRECEPT TM MEZLOCILLIN (K850833)Austin Biological Laboratories1985-09-13
PRECEPT TM AMIKACIN (K853686)Austin Biological Laboratories1985-09-13
PRECEPT KANAMYCIN (K853684)Austin Biological Laboratories1985-09-13
PRECEPT NETILMICIN 32-13 (K853687)Austin Biological Laboratories1985-09-13
PRECEPT TM TOBRAMYCIN (K853688)Austin Biological Laboratories1985-09-13
APL TRYPTIC SOY BROTH (K853609)Apl Medical Supplies1985-09-12
APL XYLOSE LYSINE DEOXYCHOLATE AGAR (K853611)Apl Medical Supplies1985-09-12
ORTHO DNA PROBE HSV CONFIRMATION TEST (K852360)Ortho Diagnostic Systems, Inc.1985-09-12
SPR 2 AUTODILUTER (K853380)Scientific Sales Intl., Inc.1985-09-12
APL BILE ESCULIN/AZIDE AGAR (K853615)Apl Medical Supplies1985-09-06
APL GN BROTH (K853613)Apl Medical Supplies1985-09-06
APL CHLAMYDOSPORE AGAR (K853616)Apl Medical Supplies1985-09-06
APL DNASE TEST AGAR (K853612)Apl Medical Supplies1985-09-06
APL FLUID THIOGLYCOLLATE MEDIUM (K853614)Apl Medical Supplies1985-09-06
ABBOTT CATION SUPPLEMENT SOLUTION (K853546)Abbott Laboratories1985-09-06
QUAD FERM + (K853544)Analytical Products, Inc.1985-09-05
PLATE INCUBATOR (K853379)Scientific Sales Intl., Inc.1985-09-03
PRECEPT ERYTHROMYCIN (K853053)Austin Biological Laboratories1985-08-29
BBL CAMPY POUCH (K853534)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-08-29
DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR (K853336)Hardy Media1985-08-29
PRECEPT AVGMENTIN (K853263)Austin Biological Laboratories1985-08-29
STAPH KIT (K853488)Culture Kits, Inc.1985-08-28
ORTHO VIRAL TRANSPORT (K853500)Ortho Diagnostic Systems, Inc.1985-08-28
HILLCREST AMEBIASIS IHA TEST (K853448)Hillcrest Biologicals1985-08-28
LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT (K852237)Genetic Systems Corp.1985-08-22
TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST (K852751)Preco, Inc.1985-08-20
ASO SLIDE EIKEN (K853276)Syn-Kit, Inc.1985-08-20
APL CHOCOLATE AGAR (K853233)Apl Medical Supplies1985-08-19
GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK (K852967)Warner-Lambert Co.1985-08-19
APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD) (K853227)Apl Medical Supplies1985-08-19
APL BIGGY AGAR(NICKERSON) (K853226)Apl Medical Supplies1985-08-19
RAPI - STAPH (K852997)Advanced Medical Technology, Inc.1985-08-19
APL HEKTOEN ENTERIC AGAR (K853235)Apl Medical Supplies1985-08-19
VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 (K851504)Ncs Diagnostics, Inc.1985-08-19
APL TSA WITH 5% SHEEP BLOOD (K853236)Apl Medical Supplies1985-08-19
APL 6.5% SODIUM CHLORIDE BROTH (K853229)Apl Medical Supplies1985-08-19
APL MUELLER HINTON AGAR (K853238)Apl Medical Supplies1985-08-19
APL MACCONKEY AGAR (K853234)Apl Medical Supplies1985-08-19
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT (K852185)Bartels Immunodiagnostic Supplies, Inc.1985-08-19
APL SABOURAUD DEXTROSE AGAR (K853231)Apl Medical Supplies1985-08-19
GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK (K852689)Warner-Lambert Co.1985-08-19
APL MANNITOL SALT AGAR (K853232)Apl Medical Supplies1985-08-19
CARIESCREEN - SM (K852987)Pharma-Medica of Scandinavia, Ltd.1985-08-19
APL LEVINE EMB AGAR (K853225)Apl Medical Supplies1985-08-19
CEFTAZIDIME 30MCG. SENI-DISC (K852873)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-08-19
APL SALMONELLA-SHIGELLA AGAR (K853228)Apl Medical Supplies1985-08-19
APL MARTIN LEWIS MEDIUM (K853237)Apl Medical Supplies1985-08-19
APL MYCOBIOTIC AGAR (K853230)Apl Medical Supplies1985-08-19
BLOOD AGAR W/AMPICILLIN, BAP W/AMPICILLIN (K853335)Hardy Media1985-08-19
SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (K852665)Syncor Intl. Corp.1985-08-13
URINE DUO (K851225)Culture Kits, Inc.1985-08-13
CEFTAZIDIME 30 MCG SENSITVITY DISCS (K852835)Difco Laboratories, Inc.1985-08-12
CHLAMYDIA (K843654)Institute Virion , Ltd.1985-08-08
Q-FEVER (K843672)Institute Virion , Ltd.1985-08-08
MYCOPLASMA SPP SEROLOGICAL REAGENTS (K852933)Microbix Biosystems, Inc.1985-08-01
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. (K853073)Marion Laboratories, Inc.1985-08-01
PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP (K852125)Kallestad Laboratories, Inc.1985-07-30
BACTEC NR-730 BACTERIAL DETECTION SYSTEM (K853011)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-07-30
QUIDEL QUEST STREP GROUP A TEST (K852806)Quidel Corp.1985-07-30
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST (K852841)Smithkline Diagnostics, Inc.1985-07-24
GENERAL DIAGNOSTICS RAPID E. COLI TEST (K852889)Warner-Lambert Co.1985-07-23
IDS RAPID SS/U SYSTEM (K852871)Innovative Diagnostic Systems, Inc.1985-07-23
NEISSERIA - KWIK PLUS (K852998)Micro-Bio-Logics1985-07-23
MUG DISK (K852886)Remel Co.1985-07-23
IDENTICULT-NEISSERIA (K852832)Scott Laboratories, Inc.1985-07-19
FISHER DIAGNOSTIC LATEST ASO TEST KIT (K852701)Allied Fisher Scientific1985-07-19
CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI (K852044)Marion Laboratories, Inc.1985-07-19
AEROMONAS AGAR(XDCA) (K852789)Gibco Laboratories Life Technologies, Inc.1985-07-19
MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE (K850269)Meridian Diagnostics, Inc.1985-07-18
PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM (K851528)Pasco Laboratories, Inc.1985-07-15
IDENTICULT-AE (K852666)Scott Laboratories, Inc.1985-07-15
GONI-KIT (K852582)Culture Kits, Inc.1985-07-12
CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS (K851372)Difco Laboratories, Inc.1985-07-12
CLED AGAR (K852578)American Laboratory Supply, Inc.1985-07-12
PHADEBACT MONOCLONAL GC OMNI TEST (K851650)Pharmacia, Inc.1985-07-12
ABBOTT TOXO-M EIA DIAGNOSTIC KIT (K850567)Abbott Laboratories1985-07-09
DERM-KIT (K852480)Culture Kits, Inc.1985-07-09
LEGIONELLA CULTURE CONFIRMATIN KIT (K851271)Gen-Probe, Inc.1985-07-08
LATEX AGGLUTINATION TEST (K851132)New Horizons Diagnostics Co.1985-07-05
CORDIA S4 -TREPONEMA PALLIDUM (K850329)Cordis Corp.1985-07-02
SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT (K851033)Syncor Intl. Corp.1985-06-21
VIRTRAN VIRAL TRANPORTER (K851378)Diagnon Corp.1985-06-21
ELISA FOR HERPES SIMPLEX VIRUS (K843077)Scientific Research1985-06-21
TIMENTIN 85 MCG. SENSI-DISC (K851622)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-06-21
ROTAVIRUS ENZYME IMMUNOASSAY (K843367)Intl. Diagnostic Laboratories, Ltd.1985-06-13
WILLCOGEN MENINGITIDIS KIT ZL25 (K851691)Wellcome Diagnostics1985-06-10
IDS RAPID E PLUS SYSTEM (K852110)Innovative Diagnostic Systems, Inc.1985-06-04
BAC-T-SCREEN (K851399)Marion Laboratories, Inc.1985-06-04
DRI-FORM PSEUDOMONAS AGAR F (K852064)Gibco Laboratories Life Technologies, Inc.1985-06-04
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 (K844762)Wellcome Diagnostics1985-06-04
LYFO-KWIK OMI KIT (K851978)Micro-Bio-Logics1985-06-04
CHAMBER V-9 PLUS AGAR (K851238)Bug City Company, Inc.1985-05-29
BACTIGEN GROUP B STREPTOCOCCUS TEST (K850772)Armkel, LLC1985-05-29
STAPHAUREX ZL30 (K851949)Wellcome Diagnostics1985-05-22
BIOGRAM (K843725)Giles Scientific, Inc.1985-05-21
VIROGEN RUBELLA MICROTITER TEST (K844436)Armkel, LLC1985-05-21
TOXOSCAN CARD TEST KIT (K850768)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-05-20
MICROSTATIC URINE TRANSPORT TUBE FOR C & S (K851387)Analytical Luminescence Laboratory, Inc.1985-05-20
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