Microbiology
6,936 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| CHL (K813615) | Dms Laboratories | 1982-02-04 |
| PIPERACILLIN 100MCG. ANTIMICROBIAL (K820019) | General Diagnostics | 1982-01-29 |
| NEISSERIA GONORRHOEAE TEST (K820007) | New Horizons Diagnostics Co. | 1982-01-29 |
| SUSCEPTROL (K820064) | American Type Culture Collection | 1982-01-28 |
| GAS GENERATING KIT, CO2 (K820010) | Oxoid U.S.A., Inc. | 1982-01-28 |
| CAMPYLOBACTER THIOGLYCOLLATE MED W/5 (K820060) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-01-28 |
| TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY (K820043) | American Dade | 1982-01-28 |
| MINIWASH II (K813640) | Dynatech Corp. | 1982-01-28 |
| PIPERACILLIN 100 MCG. SENSITIVITY DISCS (K812524) | Difco Laboratories, Inc. | 1982-01-28 |
| TOXOELISA TEST KIT (K813221) | M.A. Bioproducts | 1982-01-26 |
| PIPERACILLIN 100 MCG. SENSI DISC (K813441) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-31 |
| MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL (K813359) | American Scientific Products | 1981-12-31 |
| SYSTEK #1 EIKEN (K813164) | Syn-Kit, Inc. | 1981-12-31 |
| AFRICAN GREEN MONKEY BLOOD IN ALSERVERS (K813513) | Dutchland Laboratories, Inc. | 1981-12-31 |
| METRONIDAZOLE DIAGNOSTIC DISCS (K813509) | Oxoid U.S.A., Inc. | 1981-12-31 |
| BBL DIRECTIGEN TEST KIT (K812808) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-30 |
| CEFINASE TM DISCS (K813442) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-29 |
| RHESUS MONKEY BLOOD IN ALSEVER'S (K813512) | Dutchland Laboratories, Inc. | 1981-12-29 |
| METRONIDAZOLE 80MCG. SENSI-DISC (K813387) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-29 |
| DIRECT FA CONJUGATE FOR LEGIONELLA SP (K813339) | Springwood Microbiologicals | 1981-12-18 |
| MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK (K812994) | General Diagnostics | 1981-12-17 |
| MS-2 BACTERIAL IDENTIFICATION SYS (K813031) | Abbott Laboratories | 1981-12-17 |
| COOKED MEAT MEDIUM (K813232) | Oxoid U.S.A., Inc. | 1981-12-03 |
| SHIGELLA SERA-CHEK (K813191) | Lab Ability, Inc. | 1981-12-03 |
| EIA RUBELLA (K812787) | Gilford | 1981-11-27 |
| MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK (K812993) | General Diagnostics | 1981-11-10 |
| BACTEC RESIN CULTURE MED. 16A (K812315) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-11-10 |
| VDRL CARBON ANTIGEN (K812894) | Oxoid U.S.A., Inc. | 1981-11-06 |
| MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D (K812916) | General Diagnostics | 1981-11-06 |
| BCYE MEDIUM (K812911) | Gibco Laboratories Life Technologies, Inc. | 1981-11-06 |
| HERPES (K811021) | Immuno-Diagnostic Products, Inc. | 1981-11-05 |
| MOXALACTAM 30 MCG. SENSITIVITY DISCS (K812228) | Difco Laboratories, Inc. | 1981-10-28 |
| IDS PORPHYRIN REAGENT (K812859) | Innovative Diagnostic Systems, Inc. | 1981-10-26 |
| PENASE (K812877) | Analytab Products, Inc. | 1981-10-26 |
| API GERM TUBE (K812862) | Analytab Products, Inc. | 1981-10-26 |
| IMMUNOASSAY PLATE (K812860) | Skatron, Inc. | 1981-10-26 |
| TITERTEK AUTODROP (K812818) | Flow Laboratories, Inc. | 1981-10-23 |
| REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS (K812741) | Nolan Biological Laboratories, Inc. | 1981-10-23 |
| FORMA CH/P GAS PROCESSOR (K812826) | Forma Scientific, Inc. | 1981-10-23 |
| MOXALACTAM 30MCG. SENSI-DISC (K812844) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-10-23 |
| TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK (K812783) | General Diagnostics | 1981-10-23 |
| SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE (K812730) | Hoffmann-La Roche, Inc. | 1981-10-23 |
| SCHAEDLER AGARS (K812797) | Isle Media and Sterile Products, Inc. | 1981-10-20 |
| ANAEROBIC BLOOD AGAR (K812795) | Isle Media and Sterile Products, Inc. | 1981-10-20 |
| MOTILITY GI MEDIUM (K812798) | Isle Media and Sterile Products, Inc. | 1981-10-20 |
| REAGENTS FOR SERODIAGNOSIS OF ASPERGILL (K812740) | Nolan Biological Laboratories, Inc. | 1981-10-20 |
| ANAEROBIC CNA BLOOD AGAR (K812796) | Isle Media and Sterile Products, Inc. | 1981-10-20 |
| SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE (K812732) | Hoffmann-La Roche, Inc. | 1981-10-19 |
| SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE (K812729) | Hoffmann-La Roche, Inc. | 1981-10-19 |
| SEPTI-CHECK BLOOD CULTURE SLIDE (K812731) | Hoffmann-La Roche, Inc. | 1981-10-19 |
| GC DISK (K812698) | Remel Co. | 1981-10-06 |
| MEZLOCILLIN 75 MCG. SENSI-DISC (K812571) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-10-06 |
| MEZLOCILLIN 75 MCG. SENSITIVITY DISCS (K812525) | Difco Laboratories, Inc. | 1981-10-02 |
| MINITECK ENTERIC BROTH & ENTEROBACTER (K812286) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-10-02 |
| RABBIT COAGULASE PLASMA (K812602) | Dutchland Laboratories, Inc. | 1981-09-29 |
| BECKMAN R.PR CONTROL SERUM SET (K812425) | Beckman Instruments, Inc. | 1981-09-23 |
| PADAC (K812458) | Calbiochem-Behring Corp. | 1981-09-23 |
| TITERTEK MICROPLATE INCUBATOR (K812340) | Flow Laboratories, Inc. | 1981-09-23 |
| SENSI-TECT (K812581) | Uti-Tect, Inc. | 1981-09-23 |
| CAMPY THIOGLYCOLLATE (TUBE) (K812451) | Granite Diagnostics, Inc. | 1981-09-23 |
| DIAGNOSTIC KITS & KIT COMPONENTS (K812434) | Diagnostica, Inc. | 1981-09-23 |
| CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM (K811671) | Zeus Scientific, Inc. | 1981-09-16 |
| PGUA-INDOL MICROTUBE (K812467) | Carr Microbiologicals | 1981-09-14 |
| RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB (K812469) | Carr Microbiologicals | 1981-09-14 |
| ONPX-INDOL MEDIUM MICROTUBES (K812466) | Carr Microbiologicals | 1981-09-14 |
| PHOS MICROTUBES (K812465) | Carr Microbiologicals | 1981-09-14 |
| HIPP MICROTUBE (K812470) | Carr Microbiologicals | 1981-09-14 |
| PYRR MICROTUBE (K812468) | Carr Microbiologicals | 1981-09-14 |
| RAT BLOOD IN ALSEVER'S, CITRATED (K812368) | Dutchland Laboratories, Inc. | 1981-09-09 |
| ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. (K812374) | Dutchland Laboratories, Inc. | 1981-09-09 |
| SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR (K812376) | Dutchland Laboratories, Inc. | 1981-09-09 |
| TRYPTICASE SOY BROTH BLOOD CULTURE BOTT (K812335) | Fisher Scientific Co., LLC | 1981-09-09 |
| GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (K812367) | Dutchland Laboratories, Inc. | 1981-09-09 |
| RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR (K812373) | Dutchland Laboratories, Inc. | 1981-09-09 |
| PARA 1 SENDAI HEMAGGLUTININ (K812365) | Dutchland Laboratories, Inc. | 1981-09-09 |
| BABY CHICK BLOOD IN ALSEVER'S (K812375) | Dutchland Laboratories, Inc. | 1981-09-09 |
| GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF (K812372) | Dutchland Laboratories, Inc. | 1981-09-09 |
| PROPOSED CONTROLS FOR DOSIMETRIC RELEASE (K812068) | Hexcel Medical | 1981-09-08 |
| LEGIONELLA INDIRECT FLUOR. ANTIBODY (K812007) | Centers for Disease Control and Prevention | 1981-09-08 |
| LEGIONELLA DIRECT FLUORESCENT ANTIBODY (K812006) | Centers for Disease Control and Prevention | 1981-09-08 |
| HERPES VIRUS HOMINIS ANTIBODY TEST SYS. (K812085) | Zeus Scientific, Inc. | 1981-09-01 |
| SMITH'S SYSTEMIC FUNGAL MEDIUM (K812187) | American Scientific Products | 1981-08-31 |
| COCCIDIOIDES IMMUNODIFFUSION SYSTEM (K812190) | American Scientific Products | 1981-08-31 |
| CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI (K812188) | American Scientific Products | 1981-08-31 |
| FUNGAL IMMUNODIFFUSION SYSTEM (K812185) | American Scientific Products | 1981-08-25 |
| STAPHYLOCOCCAL PROTEIN A INSOLUBLE (K812181) | Oxoid U.S.A., Inc. | 1981-08-25 |
| CANDIDA IMMUNODIFFUSION SYSTEM (K812186) | American Scientific Products | 1981-08-25 |
| COCCIDIOIDES LATEX AGGLUTINATION (K812189) | American Scientific Products | 1981-08-25 |
| IDS RAPIDS NH SYSTEMS (K812048) | Carr-Scarborough Microbiologicals, Inc. | 1981-08-18 |
| KANAMYCIN DISK (K812082) | Remel Co. | 1981-08-13 |
| BI-ASO SLIDE TEST (K812060) | Biologics Intl., Inc. | 1981-08-13 |
| SENSITITIRE AP60 (K811765) | Gibco Laboratories Life Technologies, Inc. | 1981-08-13 |
| BILE DISK (K812083) | Remel Co. | 1981-08-13 |
| SPS DISK (K812084) | Remel Co. | 1981-08-13 |
| IDS BETA-LACTAMASE DISC (K812047) | Carr-Scarborough Microbiologicals, Inc. | 1981-08-07 |
| LUMAC'S BACTERIURIA SCREENING KIT (K810746) | Lumac | 1981-07-31 |
| STAPHASE* (K811982) | Analytical Products, Inc. | 1981-07-28 |
| FLUORESCENT ANTIBODY CONJUGATE FOR GP.A (K812013) | Springwood Microbiologicals | 1981-07-28 |
| STAPH-IDENT (K811998) | Analytical Products, Inc. | 1981-07-28 |
| GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) (K812078) | Abbott Laboratories | 1981-07-23 |
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