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Microbiology

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

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RecordFirmDate
FILTRA-CHECK-UTI (K860483)Applied Polytechnology, Inc.1986-04-04
MUREX SUDS GROUP A STREP (K860576)Murex Corp.1986-04-04
KULTSURE (CULTURE TRANSPORT) (K860178)Ncs Diagnostics, Inc.1986-04-04
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT (K860778)Hybritech, Inc.1986-04-04
VIRTRAN VIRAL TRANSPORTER (MODIFIED) (K860967)Diagnon Corp.1986-04-04
MICRO-MEDIA MICRODILUTION TEST PANELS (K853805)Beckman Instruments, Inc.1986-03-19
CAMPYLOBACTER CVA AGAR (K860862)Gibco Laboratories Life Technologies, Inc.1986-03-18
DIFCO STREP A LATEX TEST (K854978)Difco Laboratories, Inc.1986-03-18
MCBRIDE LISTERIA AGAR (K860861)Gibco Laboratories Life Technologies, Inc.1986-03-14
RUBALEX (K852788)Orion Corp.1986-03-12
OXOID STREPTOCOCAL GROUPING KIT (K854929)Oxoid U.S.A., Inc.1986-03-11
DIFFERENTIATION DISKS VANCOMYCIN 5 MCG (K860563)Difco Laboratories, Inc.1986-03-11
DIFFERENTIATION DISKS PENICILLIN G 2 UNITS (K860561)Difco Laboratories, Inc.1986-03-11
DIFFERENTIATION DISKS KANAMYCIN 1000 MCG (K860565)Difco Laboratories, Inc.1986-03-11
DIFFERENTIATION DISKS RIFAMPIN 15 MCG (K860560)Difco Laboratories, Inc.1986-03-11
NEISSERIASTAT (K860156)Richardson Scientific, Inc.1986-03-11
OFPBL (K860707)Remel Co.1986-03-11
API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC (K860369)Analytical Products, Inc.1986-03-11
DIFFERENTIATION DISKS ERYTHROMYCIN 60 MCG (K860564)Difco Laboratories, Inc.1986-03-11
DIFFERENTIATION DISKS COLISTIN 10 MCG (K860562)Difco Laboratories, Inc.1986-03-11
CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT (K860179)Difco Laboratories, Inc.1986-03-10
PSEUDOMONAS AGAR P (MEDIUM A) (K860750)Gibco Laboratories Life Technologies, Inc.1986-03-10
HSV IDR (K854974)Genus Diagnostics1986-03-07
API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) (K854733)Dms Products, Inc.1986-03-06
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK (K860031)Organon Teknika Corp.1986-03-06
IMIPENEM SUSCEPTIBILITY POWDER (K855071)Merck, Sharp & Dohme1986-03-06
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 (K855106)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-03-06
KULTSURE (CATALOGUE NO. M200) (K860655)Ncs Diagnostics, Inc.1986-03-06
IMIPENEM 10 MCG SENSITIVITY DISCS (K855207)Difco Laboratories, Inc.1986-03-06
API 50 CHB (CULTURE MEDIA) (K854732)Dms Products, Inc.1986-03-04
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT (K853009)Roche Diagnostic Systems, Inc.1986-03-04
ROTALEX (K860529)Orion Corp.1986-03-04
NEG COMBO BREAKPOINT PANEL POS COMBO (K854278)American Micro Scan1986-03-04
INSTA KIT FOR GROUP A STREP ID (K860247)Mead Johnson & Co.1986-03-04
KULTSURE (CATALOGUE NO. M240) (K860657)Ncs Diagnostics, Inc.1986-03-04
KULTSURE (CATALOGUE NO. M210) (K860656)Ncs Diagnostics, Inc.1986-03-04
KULTSURE (CATALOGUE NO. M250) (K860658)Ncs Diagnostics, Inc.1986-03-04
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS (K860153)Oxoid U.S.A., Inc.1986-03-04
CEFOTETAN 30 MCG SENSITIVITY DISCS (K860527)Difco Laboratories, Inc.1986-03-03
V-TREND KIT STAPH LATEX TEST (K855220)Texas Immunology, Inc.1986-03-03
POLYPET (K860617)Instrumed, Inc.1986-03-03
QUADRA-TITER I.D. (K860208)Microtech Medical Systems, Inc.1986-03-03
CEFOTETAN 30 MCG SENSI DISC (K860536)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-03-03
BIOTIS HAEMPHILLUS ISOLATION AGAR (K860395)Otisville Biotech, Inc.1986-02-24
BIOTIS NUTRIENT AGAR (K860408)Otisville Biotech, Inc.1986-02-24
LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER) (K854719)Xsirius Scientific, Inc.1986-02-24
BIOTIS REGAN-LOWE (K860416)Otisville Biotech, Inc.1986-02-24
BIOTIS TODD HEWITT BROTH (K860399)Otisville Biotech, Inc.1986-02-24
BIOTIS MODIFIED THAYER MARTIN (K860384)Otisville Biotech, Inc.1986-02-24
BIOTIS SF BROTH (K860386)Otisville Biotech, Inc.1986-02-24
BIOTIS MIDDLEBROOK 7H10 AGAR SLANT (K860404)Otisville Biotech, Inc.1986-02-24
BIOTIS TSA (K860397)Otisville Biotech, Inc.1986-02-24
BIOTIS TRYPTIC SOY AGAR SLANTS (K860401)Otisville Biotech, Inc.1986-02-24
BIOTIS TSI (K860413)Otisville Biotech, Inc.1986-02-24
BIOTIS MIDDLEBROOK 7H9 BROTH (K860406)Otisville Biotech, Inc.1986-02-24
BIOTIS TSB WITH 6.5% NACL (K860405)Otisville Biotech, Inc.1986-02-24
BIOTIS BISMUTH SULFITE AGAR (K860402)Otisville Biotech, Inc.1986-02-24
BIOTIS ORNITHINE INDOLE MOTILITY MEDIA (K860414)Otisville Biotech, Inc.1986-02-24
BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN (K860390)Otisville Biotech, Inc.1986-02-24
BIOTIS CETRIMIDE AGAR (K860394)Otisville Biotech, Inc.1986-02-24
BIOTIS COOKED MEAT (K860410)Otisville Biotech, Inc.1986-02-24
BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT (K860391)Otisville Biotech, Inc.1986-02-24
BIOTIS BHI AGAR (K860411)Otisville Biotech, Inc.1986-02-24
BIOTIS KF STREPTOCOCCUS AGAR (K860388)Otisville Biotech, Inc.1986-02-24
BIOTIS NUTRIENT GELATIN (K860396)Otisville Biotech, Inc.1986-02-24
BIOTIS SIM MEDIUM (K860412)Otisville Biotech, Inc.1986-02-24
BIOTIS SIMMON CITRATE AGAR (K860415)Otisville Biotech, Inc.1986-02-24
BIOTIS MAC-MUG (K860385)Otisville Biotech, Inc.1986-02-24
BIOTIS ANAEROBIC CNA (K860407)Otisville Biotech, Inc.1986-02-24
BIOTIS CLOSTRIDIUM DIFFICILE AGAR (K860383)Otisville Biotech, Inc.1986-02-24
BIOTIS POTATO DEXTROSE AGAR (K860398)Otisville Biotech, Inc.1986-02-24
BIOTIS TSA WITH 5% RABBIT BLOOD (K860403)Otisville Biotech, Inc.1986-02-24
BIOTIS COLUMBIA SHEEP BLOOD AGAR (K860409)Otisville Biotech, Inc.1986-02-24
PARA-PAK MACRO-CON (K860034)Meridian Diagnostics, Inc.1986-02-21
PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE (K860195)Austin Biological Laboratories1986-02-20
AUSTIN ENTERIC SYSTEM (K860194)Austin Biological Laboratories1986-02-20
KWI (TM) G-CO/TWO (K855172)Micro-Bio-Logics1986-02-20
RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE (K860301)Carr-Scarborough Microbiologicals, Inc.1986-02-06
PYR DISCS (K860302)Carr-Scarborough Microbiologicals, Inc.1986-02-05
PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) (K854577)Austin Biological Laboratories1986-02-05
MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM (K855205)Hana Biologics, Inc.1986-02-05
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 (K854666)Clinical Sciences, Inc.1986-02-05
INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT (K853484)Biotech Research Laboratories, Inc.1986-02-05
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (K854851)Wellcome Diagnostics1986-02-04
FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (K853540)Idt, A Division of Whittaker M.A. Bioproducts1986-02-04
CYTOMEGELISA M TEST KIT (K854839)Whittaker Bioproducts, Inc.1986-02-04
ORTHO HSV ANTIGEN ELISA TEST (K854488)Ortho Diagnostic Systems, Inc.1986-02-04
WELLCOGEN BACTERIAL ANTIGEN KIT (K854852)Wellcome Diagnostics1986-02-04
MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES (K854615)Serono Diagnostics, Inc.1986-01-28
STREP D FLUOR (K860041)Bio Spec, Inc.1986-01-24
CEFACLOR 30 MCG SENSITIVITY DISCS (K855206)Difco Laboratories, Inc.1986-01-24
HSVI - IGG ELISA-KIT (K852782)Clinical Sciences, Inc.1986-01-21
BIO SPEC GRAMAFLUOR TEST KIT (K860091)Bio Spec, Inc.1986-01-21
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS (K854129)Orion Diagnostica, Inc.1986-01-21
PASCO RESISTANT 5 PANEL (K853862)Pasco Laboratories, Inc.1986-01-21
HSV2 - IGG ELISA-KIT (K852781)Clinical Sciences, Inc.1986-01-21
INDI KWIK (TM) CO/TWO KIT (K855198)Micro-Bio-Logics1986-01-14
CEFACLOR SENSI-DISC (K855135)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-01-13
CYTOMEGALOVIRUS IGG EIA TEST KIT (K843189)Labsystems, Inc.1986-01-08
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8 (K855110)Gibco Laboratories Life Technologies, Inc.1986-01-07
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