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Microbiology

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

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RecordFirmDate
RUBELISA IGM TEST KIT (K802508)M.A. Bioproducts1980-12-18
TOXOTEST-MT EIKEN KIT (K802452)Syn-Kit, Inc.1980-12-18
RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (K802102)Calbiochem-Behring Corp.1980-12-18
EIA RUBELLA-G (K802339)Beckman Instruments, Inc.1980-12-18
CYE BIPHASIC BLOOD CULTURE MEDIUM (K802571)Remel Co.1980-12-16
CULTURE MEDIA FOR IN VITRO DIAG. USE (K802892)Radiation Technology, Inc.1980-12-11
CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.) (K802753)Oxoid U.S.A., Inc.1980-12-11
IMMULON REMOVAWELL STRIPS #011-010-6301 (K802857)Dynatech Corp.1980-12-11
MS-2 IDENTIFICATION SYSTEM (K802309)Abbott Laboratories1980-12-01
GAS GENERATING KIT SYSTEM FOR CAMPYLOB. (K802494)Oxoid U.S.A., Inc.1980-11-12
MUELLER HINTON AGAR (K802498)Oxoid U.S.A., Inc.1980-11-12
BACTIRACIN DIAGNOSTIC DISC (K802497)Oxoid U.S.A., Inc.1980-11-12
G.R.A.M. SLIDE (K802509)Sterilization Technical Services, Inc.1980-11-12
X-FACTOR DISCS (K802500)Oxoid U.S.A., Inc.1980-11-12
ANAIROBE-TEK (K802626)Flow Laboratories, Inc.1980-11-12
OPTOCHIN DIAGNOSTIC DISC (K802496)Oxoid U.S.A., Inc.1980-11-12
V FACTOR DISCS (K802501)Oxoid U.S.A., Inc.1980-11-12
PHADEBACT HAEMOPHILUS TEST (K802423)Pharmacia, Inc.1980-11-12
X & V FACTOR DISCS (K802502)Oxoid U.S.A., Inc.1980-11-12
TRANSETTE SYSTEM/COLLECTION & TRANSP (K802563)Inolex Corp./Div of Biomedical1980-10-31
BETA LACTAMASE REAGENT DISK (K802566)Carr-Scarborough Microbiologicals, Inc.1980-10-31
HI VOLUME PUMPING CHAMBER (K802561)Acacia, Inc.1980-10-31
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT (K802415)Remel Co.1980-10-31
VIRAL TRANSPORT MED. (46-995-04) (K802303)Flow Laboratories, Inc.1980-10-31
LA-SPORO ANTIBODY SYSTEM (K802427)Immuno-Mycologics, Inc.1980-10-31
PHADEBACT PNEUMOCOCCUS TEST (K802337)Pharmacia, Inc.1980-10-31
ANAEROBE BLOOD AGAR (K802397)Granite Diagnostics, Inc.1980-10-23
MINOCYCLINE 30MCG. SENSI DISC (K802194)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-23
FTA-ABS BIOPAK (K802276)Bioware Products1980-10-23
E-VAC BLOOD CULTURE SYSTEM (K802408)Pfizer Pharmaceuticals1980-10-23
FTA-ABS TEST (K801959)Immuno-Diagnostic Products, Inc.1980-10-23
GAMMA COAT(125 I) RUBELLA ANTIBODY (K801667)Clinical Assays, Inc.1980-10-23
CMV TEST KIT (K801963)Immuno-Diagnostic Products, Inc.1980-10-23
MINOCYCLINE 30 MCG. SENSITIVITY DISCS (K802178)Difco Laboratories, Inc.1980-10-10
SERO STREP KIT (K801775)Sacks Farms Biological Products1980-10-10
IMMUNODIFFUSION REAGENTS/SEROLOGICAL (K802129)Nolan Biological Laboratories, Inc.1980-09-26
IMMUNO. IDENTIFICATION OF H. CAPSULATUM (K802130)Nolan Biological Laboratories, Inc.1980-09-26
IMMUNODIFFUSSION REAGENTS/SEROLOGICAL (K802128)Nolan Biological Laboratories, Inc.1980-09-26
API-CTS STREPTOCOCCUS (K801951)Analytical Products, Inc.1980-09-26
CMV BIO-BEAD TITRATION KIT (K801722)Litton Bionetics1980-09-16
HSV BIO-BEAD TITRATION KIT (K801721)Litton Bionetics1980-09-16
BACITRACIN DIFFERENTIATION DISC (K802127)Biomedia, Inc.1980-09-16
STREP B POLYVALENT FLUORO-KIT (K801876)Clinical Sciences, Inc.1980-09-16
TOXO BIO-BEAD TITRATION KIT (K801720)Litton Bionetics1980-09-16
ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (K801098)Flow Laboratories, Inc.1980-09-16
SPOR-TEST CULTURE MEDIA (K801980)Mdt Corp., Inc.1980-09-09
CULSWAB CAT.#978 & 979 (K802023)Pollak (Intl.), Ltd.1980-09-09
BRAIN HEART INFUSION MICROBIOLOGICAL (K801943)Radiation Technology, Inc.1980-09-09
TEST PANEL FOR PRESUMP. ID/BACT. ORG (K801547)Micro-Media Systems, Inc.1980-09-09
SALMONELLA FLAGELLAR A ANTIGEN & B (K801693)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-08-27
MICROBIOLOGY CULTURE MEDIA, C.L.E.D. (K801817)Radiation Technology, Inc.1980-08-27
LAB-TEK FTA-ABS KIT (K801928)Miles Laboratories, Inc.1980-08-20
ENZYME-ASE I TUBES (K801915)Microchemical Specialities, Co.1980-08-20
ORNITH-ASE TUBES (K801916)Microchemical Specialities, Co.1980-08-20
MUELLER HINTON AGAR (K801901)Radiation Technology, Inc.1980-08-20
ANTIGEN CONTROL CELLS (K801507)Ortho Diagnostics, Inc.1980-08-20
TRIMETHROPRIM 5MCG. SENSI DISC. (K801648)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-08-13
PORPHYRIN (ALA) DISK (K801492)Remel Co.1980-08-13
ALA SWAB (K801493)Remel Co.1980-08-13
TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA (K801847)Radiation Technology, Inc.1980-08-13
OXYMETER & TRANSOXODE (K801858)Thoracel1980-08-13
TRIMETHOPRIM 5MCG. SENSITIVITY DISCS (K801474)Difco Laboratories, Inc.1980-08-13
SPOR-O-THERM (K801462)Mdt Corp., Inc.1980-07-28
CINOXACIN 100 MCG. SENSITIVITY DISCS (K801473)Difco Laboratories, Inc.1980-07-28
HIPPURATE DISK (K801305)Remel Co.1980-07-21
DISPENSING SEROLOGICAL PIPET (K801437)Amt Corp.1980-07-14
NITRATE SWAB-RAPID TEST (K800803)Remel Co.1980-07-08
ASO QUANTUM, ANTISTREPTOLYSIN O TEST (K801177)Sclavo, Inc.1980-07-08
HIPPUR-ASE TUBES (K800816)Microchemical Specialities, Co.1980-07-08
RUBELLA BIO-BEAD TITRATION KIT (K800789)Litton Bionetics1980-06-30
MACRO-VUE RUBELLA CARD TEST (K800797)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-06-20
STREPTO-SEC TM (K801159)Organon, Inc.1980-06-20
TRYPTICASE SOY AGAR W5% SHEEP BLOOD (K800986)Quality Assurance Laboratory, Inc.1980-06-02
MUELLER HINTON AGAR (K800987)Quality Assurance Laboratory, Inc.1980-06-02
DYNAWASHER II (K800989)Dynatech Laboratories, Inc.1980-06-02
CAPIK-CANDIDA ALBICANS IDENT. KIT. (K800908)Immuno-Mycologics, Inc.1980-06-02
CHOCOLATE AGAR W/ENRICHMENTS (K800981)Quality Assurance Laboratory, Inc.1980-05-28
XYLOSE LYSINE DESOXYCHOLATE AGAR (K800978)Quality Assurance Laboratory, Inc.1980-05-28
SALMONELLA SHIGELLA AGAR (K800982)Quality Assurance Laboratory, Inc.1980-05-23
THIOGLYCOLLATE MED. W/O INDICATOR (K800985)Quality Assurance Laboratory, Inc.1980-05-23
LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE (K800899)Miles Laboratories, Inc.1980-05-23
HEXTOEN ENTERIC AGAR (K800980)Quality Assurance Laboratory, Inc.1980-05-23
THAYER-MARTIN AGAR (K800977)Quality Assurance Laboratory, Inc.1980-05-23
EOSIN METHYLENE BLUE AGAR, LEVINE (K800984)Quality Assurance Laboratory, Inc.1980-05-23
MUELLER HINTIN AGAR W/5% SHEEP BLOOD (K800979)Quality Assurance Laboratory, Inc.1980-05-23
MACCONKEY AGAR (K800983)Quality Assurance Laboratory, Inc.1980-05-23
VIRAL CULTURETTE HANK'S BAL. SALT SOL. (K800832)Marion Health & Safety, Inc.1980-05-20
RAPID FERMENTATION AGAR (RFA) (K800734)Remel Co.1980-05-08
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL) (K800745)Remel Co.1980-05-02
PHADEBACT STREP D TEST (K800159)Pharmacia, Inc.1980-04-29
NICKERSON'S MED. SELECTIVE CULTURE MEDIU (K800754)Ortho Pharmaceutical Corp.1980-04-29
GAS PAK II DIS. GENERATOR ENVELOPES (K800796)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-24
CORN MEAL AGAR MEDIA (K800807)Isle Media and Sterile Products, Inc.1980-04-24
CHLAMYDOSPORE AGAR (K800818)Isle Media and Sterile Products, Inc.1980-04-24
RAPI/TEX ASO STANDARD SERUM (K800642)Calbiochem-Behring Corp.1980-04-24
URI-DIP (R) (K800626)Pharma-Medica of Scandinavia, Ltd.1980-04-24
DISP. HYDROGEN & CO2 GENERATOR ENVELOPE (K800539)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-08
BETA-ASE TUBES (K800579)Microchemical Specialities, Co.1980-04-08
CAMPYLOBACTER AGAR W/5-ANTIMICROBICS (K800541)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-04
BACTOGEN-H. INFLUENZAE TYPE B (K800493)Armkel, LLC1980-04-04
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