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Microbiology

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

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RecordFirmDate
DERMATOPHYTE TEST MEDIUM (K880132)Hardy Media1988-03-30
NITRATE BROTH (K880135)Hardy Media1988-03-30
BRILLIANT GREEN BILE BROTH (K880129)Hardy Media1988-03-30
INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL (K881111)Sigma Diagnostics, Inc.1988-03-30
TSA W/LEC. & TWEEN. 80 (K880142)Hardy Media1988-03-30
CETRIMIDE SELECTIVE AGAR (K880136)Hardy Media1988-03-30
ACETAMIDE AGAR SLANT (K880106)Hardy Media1988-03-30
LYME STAT TEST KIT (K875286)Whittaker Bioproducts, Inc.1988-03-30
RPR TEST FOR SYPHILIS IN SERUM OR PLASMA (K880477)Ampcor, Inc.1988-03-30
ATS MEDIA (K880130)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM BASE (K880109)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM W/SUCROSE (K880111)Hardy Media1988-03-30
ONPG TEST REAGENT (K880139)Hardy Media1988-03-30
COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV (K875367)Enzo Biochem, Inc.1988-03-28
EBV-NA TEST (K880043)Gull Laboratories, Inc.1988-03-24
ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION (K880990)Alpha-Tec Systems, Inc.1988-03-24
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA (K881115)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-03-24
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT (K881125)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-23
THE DDI SERODOT RUBELLA IGG TEST KIT (K875368)Disease Detection International, Inc.1988-03-23
MODIFICATIONS TO API UNISCEPT (R) KB (K880598)Analytical Products, Inc.1988-03-23
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS (K880031)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-17
TOXO IGM TEST (K880007)Gull Laboratories, Inc.1988-03-17
ADDITION OF AMPICILLIN/SULBACTAM & CIPROFLOXACIN (K880617)Pasco Laboratories, Inc.1988-03-16
NUTRIENT BROTH (K880114)Hardy Media1988-03-08
NUTRIENT GELATIN (K880115)Hardy Media1988-03-08
TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 (K874594)Clinical Sciences, Inc.1988-03-07
POTATO DEXTROSE AGAR (K880127)Hardy Media1988-03-07
DETECTADOT SYSTEM 2000 TOXO IGG TEST (K875109)Gull Laboratories, Inc.1988-03-07
TARGET STREP A (K880460)V-Tech, Inc.1988-03-03
SLIDE CULTURE PLATE-POTATO FLAKE AGAR (K880716)Remel Co.1988-03-03
SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR (K880717)Remel Co.1988-03-03
VIROGEN CMV ANTIBODY TEST (K875101)Wampole Laboratories1988-03-01
MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT (K880665)Allelix Diagnostics, Inc.1988-03-01
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE (K874620)Gen-Probe, Inc.1988-03-01
ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST (K873082)Cambridge Bioscience Corp.1988-02-24
VIRGO(TM) MEASLES IGG ELISA (K873925)Electro-Nucleonics Laboratories, Inc.1988-02-24
EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 (K880029)Immuno-Mycologics, Inc.1988-02-24
IMAGEN INFLUENZA VIRUS A AND B TESTMI (K872958)Boots-Celltech Diagnostics, Inc.1988-02-24
ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (K873312)Cambridge Bioscience Corp.1988-02-24
RAPID COLORIMETRIC DIRECT STREP A TEST (K874761)New Horizons Diagnostics Co.1988-02-19
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT (K872632)E.I. Dupont DE Nemours & Co., Inc.1988-02-18
MICROTRAK HSV CULTURE IDENTIFICATION TEST (K880436)Syva Co.1988-02-18
PRECEPT(TM) CIPROFLOXACIN (K874727)Austin Biological Laboratories1988-02-18
RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) (K874863)Monoclonal Antibodies, Inc.1988-02-16
BIOTIS (TM) HAEMOPHILUS DUCREYI (K874176)Otisville Biopharm, Inc.1988-02-05
MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST (K880157)Syva Co.1988-02-04
V-TREND RPRL CARD TEST (K875180)Texas Immunology, Inc.1988-02-04
BIOTIS (TM) SABHI (DOUBLE POUR) (K874179)Otisville Biopharm, Inc.1988-01-28
WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (K875275)Sterling Drug, Inc.1988-01-27
BREWER GEL FOR ANAEROBES (K875362)Fairleigh Dickinson Laboratories, Inc.1988-01-27
BITEK(TM) BLOOD CULTURE SYSTEM (K875259)Definitive Diagnostics, Inc.1988-01-27
BITEK(TM) BLOOD CULTURE SYSTEM (K875273)Definitive Diagnostics, Inc.1988-01-22
COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750 (K875136)Lakewood Biochemical Co., Inc.1988-01-12
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL (K874876)Baxter Healthcare Corp1988-01-11
IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (K872942)Clinical Sciences, Inc.1988-01-11
PROSPECT/GIARDIA (K874849)Alexon Biomedical, Inc.1988-01-05
MUG-INDOLE DISC (K874933)Scott Laboratories, Inc.1988-01-05
EBV-EA TEST (K872617)Gull Laboratories, Inc.1988-01-05
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS (K874878)Gen-Probe, Inc.1987-12-29
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST (K872628)Ortho Diagnostic Systems, Inc.1987-12-21
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL (K874375)Abbott Laboratories1987-12-10
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC (K874466)Analytical Products, Inc.1987-12-09
MERITEC(TM)-GC (K874078)Meridian Diagnostics, Inc.1987-12-09
TRICHOMONAS DIRECT ENZYME IMMUNOASSAY (K874259)California Integrated Diagnostics, Inc.1987-12-07
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC (K874175)Otisville Biopharm, Inc.1987-12-04
BIOTIS (TM) BCYE (K874177)Otisville Biopharm, Inc.1987-12-04
COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (K872576)Enzo Biochem, Inc.1987-12-04
BIOTIS (TM) BCYE SELECTIVE (K874178)Otisville Biopharm, Inc.1987-12-04
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP (K874174)Otisville Biopharm, Inc.1987-12-04
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO (K874426)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-12-02
ROTASCREEN EIA (K873740)Mercia Diagnostics , Ltd.1987-11-27
CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT (K874456)Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd.1987-11-24
BINAX EQUATE STREP B (K872904)Binax, Inc.1987-11-20
AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK (K874256)Organon Teknika Corp.1987-11-20
DYNATECH MR 250 MANUAL MICROELISA READER (K874598)Dynatech Laboratories, Inc.1987-11-20
TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516 (K874538)Lakewood Biochemical Co., Inc.1987-11-20
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (K874537)Lakewood Biochemical Co., Inc.1987-11-20
GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (K873564)Genetic Systems Corp.1987-11-20
CIPROFLOXACIN 5 MCG SENSI-DISC (K874425)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-11-20
NOVA STREP A (K873784)Synbiotics Corp.1987-11-12
SPECIALTY MEDIA (K873259)Central Media1987-11-06
QUAD PLATE (4 DIFFERENT MEDIA) (K874344)Lakewood Biochemical Co., Inc.1987-11-06
CORYNEBACTERIA ISOLATION MEDIA (K873260)Central Media1987-11-06
GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA. (K873257)Central Media1987-11-06
STAPHYLASE TEST (K874303)Oxoid U.S.A., Inc.1987-11-06
TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050 (K874345)Lakewood Biochemical Co., Inc.1987-11-06
STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA (K873258)Central Media1987-11-06
ECG BASED MEDIA (K873267)Central Media1987-11-04
ACTINOMYCETE DIFFERENTIAL MEDIA (K873270)Central Media1987-11-04
MYCOLOGICAL MEDIA (K873269)Central Media1987-11-04
MUELLER HINTON MEDIA (K873268)Central Media1987-11-04
TOXOPLASMA GONDII (K864981)Virion (U.S.), Inc.1987-10-30
MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS (K873264)Central Media1987-10-28
BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI (K874173)Otisville Biopharm, Inc.1987-10-28
DIFFERENTIAL MEDIA (K873262)Central Media1987-10-28
ENTERIC ISOLATION MEDIA (K873261)Central Media1987-10-28
STAPHSLIDE (K874019)Ncs Diagnostics, Inc.1987-10-28
BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) (K874172)Otisville Biopharm, Inc.1987-10-28
MIDDLEBROOK BASED MEDIA (K873266)Central Media1987-10-28
RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS (K871878)Gen-Probe, Inc.1987-10-28
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