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Microbiology

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

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RecordFirmDate
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (K862642)American Micro Scan1986-09-11
CODE-A-WELL SERIES 1-600, 1-625 (K863374)Plastic Injectors, Inc.1986-09-11
TOXONOSTIKA IGM MICROELISA SYSTEM (K862196)Organon Teknika Corp.1986-09-11
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM (K862189)Organon Teknika Corp.1986-09-08
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (K862630)Medical Diagnostic Technologies, Inc.1986-09-03
CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN (K863289)Gibco Laboratories Life Technologies, Inc.1986-09-03
AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (K863164)Precision Dynamics Corp.1986-08-27
ANAEROBE RAPID CHROMOGENIC ID PANEL (K862332)American Micro Scan1986-08-27
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM (K862638)Isolab, Inc.1986-08-26
CELLMATICS RSV DETECTION SYSTEM (K862321)Difco Laboratories, Inc.1986-08-21
MODIFIED IDEIA CHLAMYDIA TEST (K861966)Boots-Celltech Diagnostics, Inc.1986-08-19
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM (K862320)Difco Laboratories, Inc.1986-08-19
SEROIDEN STREPTO KIT 'EIKEN' (K861098)Syn-Kit, Inc.1986-08-12
RUBELLA IGM EIA TEST KIT (K862431)Labsystems, Inc.1986-08-08
FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY (K861716)Whittaker Bioproducts, Inc.1986-08-08
VACUTAINER BRAND AGAR SLANT (K862761)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-08-04
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (K862607)Boots-Celltech Diagnostics, Inc.1986-08-04
REPLIANALYZER (K861958)Mct Medical, Inc.1986-08-01
PDQ AMEBIASIS (K862473)Diamedix Corp.1986-08-01
MULTI-CHANNEL MICROPIPETTES (K862802)Dynatech Laboratories, Inc.1986-08-01
ENZYGNOST ANTI-CMV IGM TEST (K861363)Behring Diagnostics, Inc.1986-07-21
DISPENS-O-DISC DIFFERENTIATION DISKS PYR (K862570)Difco Laboratories, Inc.1986-07-17
MICRODILUTION PANELS (K862140)American Micro Scan1986-07-16
MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT (K861379)Serono Diagnostics, Inc.1986-07-16
GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM (K860498)Gen-Probe, Inc.1986-07-16
RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 (K860145)Clinical Sciences, Inc.1986-07-14
PRECEPT CEFTAZIDIME (K862446)Austin Biological Laboratories1986-07-11
PRECEPT CEFTIZOXIME (K862560)Austin Biological Laboratories1986-07-11
CANDI-KIT TM (K854672)Culture Kits, Inc.1986-07-11
BIOTIS DECARBOXYLASE MEDIA, ARGININE (K862396)Otisville Biotech, Inc.1986-07-03
BIOTIS BORDET GENGOU AGAR (K862390)Otisville Biotech, Inc.1986-07-03
BIOTIS ACETAMIDE AGAR (K862389)Otisville Biotech, Inc.1986-07-03
BIOTIS SXT AGAR (K862399)Otisville Biotech, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, BASE (K862395)Otisville Biotech, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (K862398)Otisville Biotech, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, LYSINE (K862397)Otisville Biotech, Inc.1986-07-03
BIOTIS KV LAKED BLOOD AGAR (K862400)Otisville Biotech, Inc.1986-07-03
GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM (K860574)Gen-Probe, Inc.1986-07-03
BIOTIS LITMUS MILK (K862393)Otisville Biotech, Inc.1986-07-03
BIOTIS MITIS SALIVARIUS (K862394)Otisville Biotech, Inc.1986-07-03
BIOTIS TCBS AGAR (K862388)Otisville Biotech, Inc.1986-07-03
BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (K862387)Otisville Biotech, Inc.1986-07-03
BIOTIS DESOXYCHOLATE AGAR (K862391)Otisville Biotech, Inc.1986-07-03
BIOTIS MOTILITY TEST MEDIUM (K862392)Otisville Biotech, Inc.1986-07-03
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM (K862425)Gibco Laboratories Life Technologies, Inc.1986-07-02
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM (K860782)Gen-Probe, Inc.1986-07-02
ROTAVIRUS LATEX AGGLUTINATION ASSAY (K861172)Bartels Immunodiagnostic Supplies, Inc.1986-07-01
RAPID BACTERIURIA SCREEN (RBS) (K862195)New Horizons Diagnostics Co.1986-06-30
TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) (K862216)Labsystems, Inc.1986-06-30
HYGEIA RAPID STREP A TEST (K862133)Hygeia Sciences1986-06-25
RUBELLA IGG EIA TEST KIT (K853696)Labsystems, Inc.1986-06-17
GRAM NEGATIVE COMBO PANEL TYPE 3 (K861584)American Micro Scan1986-06-17
SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL (K861187)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-06-16
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (K862123)Marion Laboratories, Inc.1986-06-16
COR DOT CMV (K853989)Cordis Corp.1986-06-13
SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL (K861186)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-06-13
MUREX SUDS TOXO (K861458)Murex Corp.1986-06-13
MICROSCOPE SLIDES (K862112)Abco Dealers, Inc.1986-06-13
MUREX SUDS RUBELLA (K861282)Murex Corp.1986-06-13
PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (K861997)Hazleton Research Products, Inc.1986-06-10
SLIDE CULTURE U 'EIKEN' (K861631)Syn-Kit, Inc.1986-06-10
TITERTEK MICROPLATE WASHER S-12 (K862066)Flow Laboratories, Inc.1986-06-05
RUBALEX (REVISED VERSION) (K861881)Orion Corp.1986-06-04
DIRECTATEX STREP A (K861575)Pacific Biotech, Inc.1986-06-03
D'ALA RAPID TEST (K861889)Pro-Lab, Inc.1986-06-03
HIPPURATE HYDROLYSIS TEST (K861888)Pro-Lab, Inc.1986-06-03
MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST (K861835)Syva Co.1986-05-29
TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 (K860773)Clinical Sciences, Inc.1986-05-23
GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (K861824)Flow Laboratories, Inc.1986-05-20
GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (K861823)Flow Laboratories, Inc.1986-05-20
SENSITITRE AUTO ID PLATE, AP70 (K861058)Gibco Laboratories Life Technologies, Inc.1986-05-20
PENICILLIN-STREPTOMYCIN-FUNGIZONE (K861791)Flow Laboratories, Inc.1986-05-20
VISIBLE-HERPES TM TEST SYSTEM (K854712)Isolab, Inc.1986-05-20
CYTOTECH CMV IGG EIA (K860493)Cytotech, Inc.1986-05-20
QUADRA-TITER (TM) I.D. (MODIFICATION) (K861774)Microtech Medical Systems, Inc.1986-05-20
MODIFIED UNISCEPT KB LABELING AMENDMENT (K861408)Analytab Products, Inc.1986-05-16
REGAN-LOWE AGAR (K861734)Gibco Laboratories Life Technologies, Inc.1986-05-16
EZ DETECT, 5 MINUTE STREP-A COLOR TEST (K860923)Self Care Systems, Inc.1986-05-16
THE CMV-IGM TEST (K860450)Microbiological Research Corp.1986-05-13
DIRECTIGEN COMBO MENINGITIS TEST (K860768)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-05-13
YEAST IDENTIFICATION PANEL (K860575)American Micro Scan1986-05-13
CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT (K860279)Bartels Immunodiagnostic Supplies, Inc.1986-05-13
LEECO-SCREEN, STREP A (EIA) (K860947)Leeco Diagnostics, Inc.1986-05-13
CHARCOAL AGAR BASE (K861480)Gibco Laboratories Life Technologies, Inc.1986-05-06
SENSITITRE SUSCEPTIBILITY PLATES (K860753)Gibco Laboratories Life Technologies, Inc.1986-05-06
SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 (K861460)Widran Urological Group, Ltd.1986-05-02
CORDOT R (K854618)Cordis Corp.1986-05-01
CHLAMYSET ANTIGEN (K853401)Orion Corp.1986-04-28
EBV(EPSTEIN-BARR VIRUS) TEST KIT (K854207)Immuno-Diagnostic Products, Inc.1986-04-24
CORDIA CMV-M (K853889)Cordis Corp.1986-04-21
LATEX R. TYPHI (K860557)Health Research, Inc.1986-04-21
BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 (K861301)Troy Biologicals, Inc.1986-04-21
LYFO-KWIK (TM) COAGULASE PLASMA (K861312)Micro-Bio-Logics1986-04-18
REUMAGEN ASL (K854991)Biokit USA, Inc.1986-04-18
MACCONKEY W/MUG (K861259)Remel Co.1986-04-11
FOX FASTIDIOUS TEST PANEL (K854525)Beckman Instruments, Inc.1986-04-11
CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK (K860895)Organon Teknika Corp.1986-04-11
CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI) (K861080)Difco Laboratories, Inc.1986-04-07
URICHECK (K860905)Difco Laboratories, Inc.1986-04-04
KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022)Micro-Bio-Logics1986-04-04
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