Microbiology
6,936 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| #50003 QUAD DIAGNOSTIC SYSTEM (K821302) | Biomedia, Inc. | 1982-06-01 |
| TRYPTIC SOY AGAR W/5% SHEEP BLOOD (K821424) | Interstate Media | 1982-06-01 |
| MACCONKEY AGAR (K821423) | Interstate Media | 1982-06-01 |
| HEKTOEN ENTERIC AGAR (K821421) | Interstate Media | 1982-06-01 |
| XLD AGAR (K821431) | Interstate Media | 1982-06-01 |
| #50002 QUAD DIAGNOSTIC SYSTEM (K821301) | Biomedia, Inc. | 1982-06-01 |
| SALMONELLA I.D. (K821338) | Analytical Products, Inc. | 1982-05-28 |
| SHIGELLA I.D. (K821337) | Analytical Products, Inc. | 1982-05-28 |
| VD ALERT (K820520) | Intl. Research Distributors, Inc. | 1982-05-14 |
| CAMPY-S AGAR (K821218) | Isle Media and Sterile Products, Inc. | 1982-05-14 |
| MERITECASTREP (TM) (K821100) | Meridian Diagnostics, Inc. | 1982-05-13 |
| BI PLATE-XLD/HEKTOEN #30012 (K821108) | Biomedia, Inc. | 1982-05-13 |
| MEZLIN DIAGNOSTIC REAGENT (K820578) | Miles Pharmaceuticals | 1982-05-12 |
| AMS GRAM-POSITIVE IDENTIFICATION CARD (K820264) | Vitek Systems, Inc. | 1982-05-03 |
| MICROPLATE WASHING DEVICE (K820992) | Skatron, Inc. | 1982-05-03 |
| CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI (K820895) | Bartels Immunodiagnostic Supplies, Inc. | 1982-05-03 |
| SALMONELLA & SHIGELLA GROUPING SERA (K820996) | Fisher Scientific Co., LLC | 1982-05-03 |
| RAPID SST (K821040) | Mds Laboratories, Inc. | 1982-05-03 |
| ANTIMICROBIAL SUSCEP. TEST, MUELLER (K820846) | Blue Ridge Media Co. | 1982-04-16 |
| CULTURE MEDIA, NON-SELECTIVE/DIFFER (K820842) | Blue Ridge Media Co. | 1982-04-16 |
| FITC ANTI-RABIES MONOCLONAL GLOBULIN (K820499) | Centocor, Inc. | 1982-04-16 |
| ISOLATION OF PATHOGENIC NEISSERIA (K820847) | Blue Ridge Media Co. | 1982-04-16 |
| CULTURE MEDIA SELECTIVE BROTH (K820843) | Blue Ridge Media Co. | 1982-04-16 |
| CULTURE MEDIA, SELECTIVE & DIFFERENTIAL (K820844) | Blue Ridge Media Co. | 1982-04-16 |
| MEDIA FOR IN-VITRO DIAGNOSTIC USE (K820863) | Isle Media and Sterile Products, Inc. | 1982-04-16 |
| BLUE RIDGE RABBIT BLOOD (K820849) | Blue Ridge Media Co. | 1982-04-16 |
| BLUE RIDGE SHEEP BLOOD (K820848) | Blue Ridge Media Co. | 1982-04-16 |
| DULTURE MEDIA, SELECTIVE & NON-DIFFER (K820845) | Blue Ridge Media Co. | 1982-04-16 |
| CULTURE MEDIA, MULTIPLE BIOCHEMICAL (K820841) | Blue Ridge Media Co. | 1982-04-16 |
| CULTURE MEDIA, SINGLE BIOCHEM. TEST (K820839) | Blue Ridge Media Co. | 1982-04-16 |
| CULTURE MEDIA, GENERAL NUTRIENT BROTH (K820840) | Blue Ridge Media Co. | 1982-04-16 |
| MIC-2000 PLUS, 96 CHANNEL DISPENSER (K820821) | Dynatech Corp. | 1982-04-14 |
| HISTOSET IMMUNOPEROXIDASE TISSURE KIT (K820390) | Immulok, Inc. | 1982-04-14 |
| ENDO-STAPH TEICHOIC ACID ANTIBODY KIT (K820531) | Meridian Diagnostics, Inc. | 1982-04-14 |
| STAPHYLOCOCCUS LATEX AGGLUTINATION KIT (K820683) | American Scientific Products | 1982-04-14 |
| TREP CARD EIKEN (K820567) | Syn-Kit, Inc. | 1982-04-14 |
| #2007 XLD (K820801) | Biomedica, Inc. | 1982-04-08 |
| #50001 QUADE DIAGNOSTIC SYSTEM (K820797) | Biomedica, Inc. | 1982-04-08 |
| #4006 TSB-TUBED MEDIA (K820795) | Biomedica, Inc. | 1982-04-08 |
| #19012 CHOCOLATE MUELLER HINTON-150X15MM (K820794) | Biomedica, Inc. | 1982-04-08 |
| #4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE (K820810) | Biomedica, Inc. | 1982-04-08 |
| #2008 SIMMONS CITRATE (K820809) | Biomedica, Inc. | 1982-04-08 |
| #2013 CNA 5% SHEEP BLOOD (K820804) | Biomedica, Inc. | 1982-04-08 |
| #2011 STREP SELECTIVE AGAR (K820807) | Biomedica, Inc. | 1982-04-08 |
| #2003 MYCOBIOTIC AGAR (K820803) | Biomedica, Inc. | 1982-04-08 |
| #4005 TSA SLANT-TUBED MEDIA (K820791) | Biomedica, Inc. | 1982-04-08 |
| ASO SURE (K820785) | Analytical Products, Inc. | 1982-04-08 |
| #2002 MANNITOL SALT AGAR (K820799) | Biomedica, Inc. | 1982-04-08 |
| ASO SURE PLUS (K820786) | Analytical Products, Inc. | 1982-04-08 |
| #2006 SALMONELLA SHIGELLA AGAR (K820800) | Biomedica, Inc. | 1982-04-08 |
| #2009 BIGGY AGAR (K820802) | Biomedica, Inc. | 1982-04-08 |
| #2005 SABOURAUD DEXTROSE AGAR/#4002 SLA (K820805) | Biomedica, Inc. | 1982-04-08 |
| #2004 PHENYLETHYL ALCHOL AGAR W/SHEEP BL (K820806) | Biomedica, Inc. | 1982-04-08 |
| #1904L MUELLER HINTON W/5% SHEEP BLOOD (K820793) | Biomedica, Inc. | 1982-04-08 |
| #4001 TUBED MEDIA - FLUID THIOGLYCOLLATE (K820796) | Biomedica, Inc. | 1982-04-08 |
| #2001 HEKTOEN (K820798) | Biomedica, Inc. | 1982-04-08 |
| #19041-150X15MM MUELLER HINTON (K820792) | Biomedica, Inc. | 1982-04-08 |
| PHENYLETHANOL AGAR W/5% SHEEP BLOOD (K820560) | American Laboratory Supply, Inc. | 1982-03-19 |
| DERMATHPHYTE TEST MEDIUM (K820557) | American Laboratory Supply, Inc. | 1982-03-19 |
| ANAEROBE BLOOD AGAR (K820559) | American Laboratory Supply, Inc. | 1982-03-19 |
| SABOURAUD DEXTROSE AGAR (K820561) | American Laboratory Supply, Inc. | 1982-03-19 |
| POTATO DEXTROSE AGAR (K820550) | American Laboratory Supply, Inc. | 1982-03-19 |
| BRUCELLA AGAR W/15% SHEEP BLOOD (K820551) | American Laboratory Supply, Inc. | 1982-03-19 |
| CAMPYLOBACTER SELECTIVE MEDIUM (K820562) | American Laboratory Supply, Inc. | 1982-03-19 |
| COLUMBIZ CNA AGAR W/15% SHEEP BLOOD (K820554) | American Laboratory Supply, Inc. | 1982-03-16 |
| ANAEROBE BLOOD AGAR W/KANAMYCIN & VANCO (K820555) | American Laboratory Supply, Inc. | 1982-03-16 |
| THIOGLYCOLLATE ENRICHED (K820563) | American Laboratory Supply, Inc. | 1982-03-16 |
| BILE ESCULIN AZIDE AGAR (K820553) | American Laboratory Supply, Inc. | 1982-03-16 |
| THIOGLYCOLLATE W/INDICATOR (K820549) | American Laboratory Supply, Inc. | 1982-03-16 |
| EOSIN METHYLENE BLUE AGAR (K820552) | American Laboratory Supply, Inc. | 1982-03-16 |
| SELENITE BROTH (K820558) | American Laboratory Supply, Inc. | 1982-03-16 |
| TRYPTIC SOY AGAR (K820556) | American Laboratory Supply, Inc. | 1982-03-16 |
| IDA RAPID O2A SYSTEM (K820483) | Innovative Diagnostic Systems, Inc. | 1982-03-15 |
| PROMPT INOCULATION SYSTEM (K820299) | 3M Company | 1982-03-15 |
| HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (K820192) | Hyland Therapeutic Div., Travenol Laboratories | 1982-03-11 |
| CALI-PIPETTE (K820346) | Carr-Scarborough Microbiologicals, Inc. | 1982-03-04 |
| CIN AGAR BASE (K820295) | Gibco Laboratories Life Technologies, Inc. | 1982-03-04 |
| ACCU-STAPH (K820347) | Carr-Scarborough Microbiologicals, Inc. | 1982-03-04 |
| CALI-LOOP (K820345) | Carr-Scarborough Microbiologicals, Inc. | 1982-03-04 |
| ENZYGNOST TM RUBELLA IGM (K813493) | Calbiochem-Behring Corp. | 1982-03-04 |
| ANA-DISC SYSTEM (K820308) | Flow Laboratories, Inc. | 1982-03-04 |
| RAPID ZYME (K813612) | Dms Laboratories | 1982-02-22 |
| RAPID CH (K813613) | Dms Laboratories | 1982-02-22 |
| WELLCOGEN GROUP B (K820069) | Burroughs Wellcome Co. | 1982-02-18 |
| ZYME B (K820209) | Dms Laboratories | 1982-02-12 |
| IND (K820210) | Dms Laboratories | 1982-02-12 |
| NINHYDRIN (K820211) | Dms Laboratories | 1982-02-12 |
| SALINE SOLUTION (K820213) | Dms Laboratories | 1982-02-12 |
| OXI (K820212) | Dms Laboratories | 1982-02-12 |
| PYR BROTH (K820149) | Carr-Scarborough Microbiologicals, Inc. | 1982-02-05 |
| VP 2 (K820205) | Dms Laboratories | 1982-02-05 |
| NIT 1 (K820206) | Dms Laboratories | 1982-02-05 |
| SUCROSE (K820214) | Dms Laboratories | 1982-02-05 |
| COAGULASE PLASMA (K820177) | Quadroma, Inc. | 1982-02-05 |
| VP I (K820204) | Dms Laboratories | 1982-02-05 |
| NIT 2 (K820207) | Dms Laboratories | 1982-02-05 |
| CHE (K813611) | Dms Laboratories | 1982-02-04 |
| RAPID STREP (K813610) | Dms Laboratories | 1982-02-04 |
| RAPID E (K813609) | Dms Laboratories | 1982-02-04 |
| STAPH TRAC (K813614) | Dms Laboratories | 1982-02-04 |
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