Microbiology
6,936 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| RAPID PLASMA REAGIN CARD TEST (K842541) | Clinical Sciences, Inc. | 1984-07-26 |
| CEFONICID 30 MCG SENSI-DISC (K842252) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-07-20 |
| BECTEC NR-660 BACTERIAL DETECT SYS (K842279) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-07-20 |
| GNC PLUS (K842587) | Vitek Systems, Inc. | 1984-07-20 |
| GENERAL DIAG. CEFONICID 30MCG ANTIMIC (K842307) | General Diagnostics | 1984-07-20 |
| CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT (K842151) | Bartels Immunodiagnostic Supplies, Inc. | 1984-07-20 |
| STREP-A-CHEK (K842600) | E-Y Laboratories, Inc. | 1984-07-11 |
| BACTIGEN - N.MENNINIGITIDIS TEST (K841907) | Armkel, LLC | 1984-07-06 |
| LYFO-DISK MICROORGANISMS (K842129) | Micro-Bio-Logics | 1984-07-03 |
| SPOTTEST LACTOPHENOL COTTON BLUE STAIN (K842086) | Difco Laboratories, Inc. | 1984-07-03 |
| PATHO DX LATEX AGGLUTINATION STREP A (K842383) | Diagnostic Products Corp. | 1984-07-02 |
| VENTRESCREEN STREP A TEST (K842239) | Ventrex Laboratories, Inc. | 1984-07-02 |
| BIOTIS LD-PRESUMPTO QUADRANT PLATE (K842424) | Otisville Biotech, Inc. | 1984-07-02 |
| RIM STREP KIT (K842451) | Austin Biological Laboratories | 1984-07-02 |
| ZINC DUST SUSPENSION (K842299) | Irvine Diagnostic Services | 1984-06-26 |
| ORTHO VARICELLA-ZOSTER VIRUS IDENT. (K841526) | Ortho Diagnostic Systems, Inc. | 1984-06-25 |
| OXIDASE TEST STRIPS-OXIDASESURE (K842298) | Irvine Diagnostic Services | 1984-06-25 |
| SPOT TEST NINHYDRIN REAGENTS (K842290) | Difco Laboratories, Inc. | 1984-06-22 |
| SPOT TEST CATALASE TEST (K842291) | Difco Laboratories, Inc. | 1984-06-22 |
| ONPG DISKS (K842300) | Irvine Diagnostic Services | 1984-06-22 |
| ARGINIE BROTH (K842297) | Remel Co. | 1984-06-22 |
| RIM H2S (K842098) | Austin Biological Laboratories | 1984-06-19 |
| MICROTRAKSPECIMAN ID TYPING TEST CONTR (K841191) | Syva Co. | 1984-06-19 |
| AS LATEX PLUS (K842256) | Biokit USA, Inc. | 1984-06-19 |
| RUBELLA ANTIBODY FLUOROIMMUNOASSAY (K841174) | Intl. Diagnostic Technology | 1984-06-07 |
| MANNITOL SALT AGAR (K841747) | The Montana Deaconess Medical Center | 1984-06-07 |
| COBA AGAR (K842101) | Acumedia Manufacturers, Inc. | 1984-06-07 |
| XYLOSE-LYSINE DESOXYCHOLATE AGAR (K841752) | The Montana Deaconess Medical Center | 1984-06-07 |
| MACCONKEY AGAR, PLUS (K842100) | Acumedia Manufacturers, Inc. | 1984-06-07 |
| DRIGALSKI LITMUS LACTOSE AGAR (K841659) | Oxoid U.S.A., Inc. | 1984-06-07 |
| MACLEAN-FOGG, DISPOS-INOCULA-LOOPS (K842057) | Polymer Technology Corp. | 1984-06-07 |
| V.D.T.-GONORRHEA TEST KIT (K840799) | M.G. Laboratories, Inc. | 1984-06-07 |
| RIM SPOT INDOLE (K842097) | Austin Biological Laboratories | 1984-06-07 |
| MAXIMUM RECOVERY DILUENT (K841662) | Oxoid U.S.A., Inc. | 1984-06-07 |
| MACCONKEY AGAR (K841753) | The Montana Deaconess Medical Center | 1984-06-07 |
| L-ALANINE-4-NITROANILIDE (K842072) | Irvine Diagnostic Services | 1984-06-07 |
| BIPHASIC BLOOD CULTURE BOTTLE (K842036) | Gibco Laboratories Life Technologies, Inc. | 1984-06-01 |
| SHEEP BLOOD AGAR (K841748) | The Montana Deaconess Medical Center | 1984-05-31 |
| DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR (K841844) | Microline Scientific | 1984-05-31 |
| DIFFERENTIAL CULTURE MED. LEVINE EMB (K841843) | Microline Scientific | 1984-05-31 |
| LEVINE EOSIN METHYLENE BLUE AGAR (K841751) | The Montana Deaconess Medical Center | 1984-05-31 |
| CHOCOLATE AGAR (K841749) | The Montana Deaconess Medical Center | 1984-05-31 |
| CHOCOLATE AGAR (K841586) | Microline Scientific | 1984-05-31 |
| SALMONELLA-SHIGELLA AGAR (K841746) | The Montana Deaconess Medical Center | 1984-05-31 |
| MARTIN-LEWIS AGAR (K841750) | The Montana Deaconess Medical Center | 1984-05-31 |
| DIFFERENTIAL CULTURE MED. MACCONKEY AGAR (K841842) | Microline Scientific | 1984-05-31 |
| SELECTIVE CULTURE MED. COLUMBIA CNA (K841845) | Microline Scientific | 1984-05-31 |
| CODE-A-WELL SERIES 200 PLATE (K841632) | Plastic Injectors, Inc. | 1984-05-25 |
| SELECTIVE CULTURE MED. PHENYLETHYL ALCO (K841840) | Microline Scientific | 1984-05-25 |
| DIFFERENTIAL CULTURE MED. MANNITOL SALT (K841841) | Microline Scientific | 1984-05-25 |
| SELECTIVE CULTURE MED. SELECTIVE STREP (K841839) | Microline Scientific | 1984-05-25 |
| CODE-A-WELL SERIES 300 PLATE (K841937) | Plastic Injectors, Inc. | 1984-05-22 |
| CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- (K833447) | Bartels Immunodiagnostic Supplies, Inc. | 1984-05-21 |
| RUBELLA IGG ANTIBODY ELISA TEST SYS (K841200) | Ortho Diagnostic Systems, Inc. | 1984-05-21 |
| HAEMOPHILUS ISOLATION AGAR 2827 (K841673) | Gibco Laboratories Life Technologies, Inc. | 1984-05-21 |
| ENRICHED CULTURE MED. TRYPTIC SOY AGAR (K841838) | Microline Scientific | 1984-05-21 |
| ENRICHED CULTURE MED. FLUID THIOGLYC0 (K841837) | Microline Scientific | 1984-05-21 |
| TOXO-G EIA DIAGNOSTIC KIT (K840879) | Abbott Laboratories | 1984-05-21 |
| CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP (K841834) | Microline Scientific | 1984-05-14 |
| MUELLER-HINTON AGAR (K841755) | The Montana Deaconess Medical Center | 1984-05-14 |
| CULTURE MEDIUM FOR PATHOGENIC NEISSER (K841833) | Microline Scientific | 1984-05-14 |
| SELECTIVE CULTURE MED. TRICHOMONAS (K841836) | Microline Scientific | 1984-05-14 |
| MULTIPURPOSE CULTURE MEDIUM (K841835) | Microline Scientific | 1984-05-14 |
| SYNTHETIC BROTH A.O.A.C. (K841661) | Oxoid U.S.A., Inc. | 1984-05-11 |
| KF STREPTOCOCCUS AGAR (K841658) | Oxoid U.S.A., Inc. | 1984-05-11 |
| PRESTON CAMPYLOBACTER SELECTIVE SUPP (K840330) | Oxoid U.S.A., Inc. | 1984-05-11 |
| CAMPYLOBACTER AGAR BASE (K840332) | Oxoid U.S.A., Inc. | 1984-05-11 |
| LEGIONELLA BMPA SELECTIVE SUPPLE (K840333) | Oxoid U.S.A., Inc. | 1984-05-11 |
| HEKTOEN ENTERIC AGAR (K841745) | The Montana Deaconess Medical Center | 1984-05-11 |
| LEGIONELLA MWY SELECTIVE SUPPLEMENT (K840331) | Oxoid U.S.A., Inc. | 1984-05-11 |
| MICROTRAK HSV 1 & 2 CULTURE (K840494) | Syva Co. | 1984-05-07 |
| MUELLER-HINTON BROTH (K841560) | Gibco Laboratories Life Technologies, Inc. | 1984-05-07 |
| COLUMBIA CNA AGAR (K841754) | The Montana Deaconess Medical Center | 1984-05-07 |
| DIFFERENTIATION DISKS SPECTINOMYCIN (K841453) | Difco Laboratories, Inc. | 1984-05-02 |
| HSV ANTIGEN ELISA KIT (K834449) | Ortho Diagnostic Systems, Inc. | 1984-05-02 |
| RIM GARDNERELLA VAGINALIS KIT (K841460) | Austin Biological Laboratories | 1984-05-02 |
| WELLCOGEN S. PNEUMONIAE (K841376) | Wellcome Diagnostics | 1984-05-02 |
| DIRECTIGEN MENNINGITIS TEST KIT (K841308) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-05-02 |
| CODE-A-WELL (K841390) | Plastic Injectors, Inc. | 1984-05-02 |
| RIM-DNASE KIT (K841389) | Austin Biological Laboratories | 1984-05-02 |
| CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II (K833089) | Clinical Sciences, Inc. | 1984-05-02 |
| RIM ONPG KIT (K841329) | Austin Biological Laboratories | 1984-05-02 |
| BIO SPEC STREP-A-FLUOR TEST KIT (K841479) | Bio Spec, Inc. | 1984-04-25 |
| TOXOPLASMA GOND II IGG DIA TEST KIT (K833829) | Labsystems, Inc. | 1984-04-24 |
| RIM-HIPPURATE (K841277) | Austin Biological Laboratories | 1984-04-20 |
| RIM-BILE ESCULIN TEST (K841262) | Austin Biological Laboratories | 1984-04-20 |
| RIM 6.5% NACL (K841508) | Austin Biological Laboratories | 1984-04-20 |
| RIM - NITRATE TEST (K841270) | Austin Biological Laboratories | 1984-04-20 |
| MULTIPLE BIOCHEMICAL TEST (K841204) | Smith River Biologicals | 1984-04-17 |
| PORPHYRIN TEST AGAR (K840685) | Remel Co. | 1984-04-17 |
| RUBAQUICK DIAGNOSTIC KIT (K834032) | Abbott Laboratories | 1984-04-17 |
| CAMPYLOBACTER THIOGLYCOLLATE MED (K841303) | Anaerobe Systems | 1984-04-17 |
| SELECTIVE AND DIFFERENTIAL (K841209) | Smith River Biologicals | 1984-04-17 |
| HAEMOPHILUS ID QUAD-PLATE (K841304) | Gibco Laboratories Life Technologies, Inc. | 1984-04-17 |
| NON-SELECTIVE & DIFFERENTIAL (K841206) | Smith River Biologicals | 1984-04-17 |
| NON-SELECTIVE & NON-DIFFERENTIAL (K841207) | Smith River Biologicals | 1984-04-17 |
| HAEMOPHILUS I.D. II TRIPLATE (K840338) | Remel Co. | 1984-04-17 |
| RIFAMPIN DISC (K840614) | Remel Co. | 1984-04-13 |
| HEMASTAPH (K840553) | Remel Co. | 1984-04-13 |
| COLISTIN DISC (K840708) | Remel Co. | 1984-04-13 |
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