Microbiology
6,936 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| C.L.E.D. MEDIUM (K832573) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| MYCOSEL AGAR (K832582) | Acuderm, Inc. | 1983-09-12 |
| DTM-DERMATOPHYTE TEST MEDIUM (K832581) | Acuderm, Inc. | 1983-09-12 |
| THIOGLYCOLLATE MEDIUM (K832619) | Carroll Biological Corp. | 1983-09-12 |
| CHOCOLATE AGAR & THAYER MARTIN AGAR (K832612) | Carroll Biological Corp. | 1983-09-12 |
| ROGOSA BROTH (K832310) | Oxoid U.S.A., Inc. | 1983-09-01 |
| TCBS AGAR (K832365) | Granite Diagnostics, Inc. | 1983-09-01 |
| PHADEBACT STREP POSITIVE CONTROLS (K832248) | Pharmacia, Inc. | 1983-09-01 |
| ONPG DISCS (K832307) | Oxoid U.S.A., Inc. | 1983-08-26 |
| BILE AESCULIN DISCS (K832306) | Oxoid U.S.A., Inc. | 1983-08-24 |
| SPS DISCS (K832305) | Oxoid U.S.A., Inc. | 1983-08-24 |
| RIM-HAEMOPHILUS 2 (K832239) | Austin Biological Laboratories | 1983-08-12 |
| BBL ANAGEL POWDER (K832229) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-08-12 |
| POLYCHACO INDIRECT HEMAGGLUTINATION (K830870) | Parasitic Disease Consultants | 1983-08-12 |
| API UNISCEPT PLUS 140 INOCULATOR (K831462) | Analytical Products, Inc. | 1983-08-12 |
| RIM-HAEMOPHILUS 1 & 2 (K832051) | Austin Biological Laboratories | 1983-08-12 |
| GONOCHEK PANEL (K830756) | E-Y Laboratories, Inc. | 1983-08-12 |
| READER MICROELISA SYSTEM (K831641) | Organon Teknika Corp. | 1983-08-11 |
| MERITEC-STREP GROUP A BETA-HEMOLYTIC (K831599) | Meridian Diagnostics, Inc. | 1983-08-11 |
| ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS (K831924) | Electro-Nucleonics Laboratories, Inc. | 1983-08-11 |
| POLYCHACO INDIRECT IMMUNOFLUORESCENCE (K830869) | Parasitic Disease Consultants | 1983-08-11 |
| MULTI-TITER DISPENSER (K832203) | Hamilton Co. | 1983-08-08 |
| WASHER 6000 MICRO-C LISA SYSTEM (K831640) | Organon Teknika Corp. | 1983-08-08 |
| LEGIONELLA IFA KIT I (K831760) | Bionetic Laboratory Products | 1983-08-08 |
| IMMULON SUBSTRATE REMOVAWELL STRIPS (K832117) | Dynatech Corp. | 1983-08-08 |
| CMV RQ BIO-ENZABEAD KIT (K831343) | Litton Bionetics | 1983-08-08 |
| PIPETTE 12 CHANNEL (K831644) | Organon Teknika Corp. | 1983-08-01 |
| LYOPHILIZED MICROORGANISMS (K831653) | Austin Biological Laboratories | 1983-07-28 |
| MODIFIED SOYBEAN CASEIN DIGEST BROTH (K831671) | Isle Media and Sterile Products, Inc. | 1983-07-28 |
| HERPELISA KIT (K822883) | M.A. Bioproducts | 1983-07-26 |
| EGG YOLK AGAR (K831827) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-07-26 |
| MICROELISA COMP (K831658) | Organon Teknika Corp. | 1983-07-26 |
| POLYCHACO FIA-ABS TEST FOR SYPHILIS (K831296) | Parasitic Disease Consultants | 1983-07-26 |
| HEATING BLOCK MICROELISA SYSTEM (K831642) | Organon Teknika Corp. | 1983-07-26 |
| STRIPREADER MICROELISA SYSTEM (K831643) | Organon Teknika Corp. | 1983-07-26 |
| HSV IGM TEST (K830865) | Gull Laboratories, Inc. | 1983-07-18 |
| INDIRECT FLUORO-KIT HSV (K830623) | Clinical Sciences, Inc. | 1983-07-07 |
| HERPES SIMPLEX VIRUS TYPING REAGENTS (K830971) | Immulok, Inc. | 1983-06-30 |
| RIM-CAMP TEST (K831674) | Austin Biological Laboratories | 1983-06-30 |
| OXY-SWAB (K831673) | Austin Biological Laboratories | 1983-06-30 |
| INDIRECT FLUORESCENT ANTIBODY REAGENTS (K831026) | Zeus Technologies | 1983-06-22 |
| MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION (K830953) | Syva Co. | 1983-06-22 |
| SPECTRUM-10 (K831672) | Austin Biological Laboratories | 1983-06-22 |
| RIM BETA LACTAMASE TEST (K831654) | Austin Biological Laboratories | 1983-06-22 |
| SPECTRUM-10 (K831655) | Austin Biological Laboratories | 1983-06-17 |
| GONORRHEA TRANSETTE 1 & 3 (K831579) | Spectrum Diagnostic, Inc. | 1983-06-17 |
| ANHYDRIC INCUBATORS, CULTURE INCUBATOR (K831592) | Boekel Industries, Inc. | 1983-06-16 |
| ASO-CHECK (K831464) | Diagnostic Technology, Inc. | 1983-06-16 |
| RAPID IDENTIFI-METHOD NEISSERIA KIT (K830968) | Austin Biological Laboratories | 1983-06-16 |
| SPIA SYS FOR SOLID PHASE IMMUNOASSAYS (K831448) | R&D Systems, Inc. | 1983-06-08 |
| LA-STAPH IDENTIFICATION SYSTEM (K831918) | Immuno-Mycologics, Inc. | 1983-06-08 |
| LEGIONELLA CYE AGAR BASE & BCYE SUPPL (K831469) | Oxoid U.S.A., Inc. | 1983-06-08 |
| AMEBIASIS BIO-ENZABEAD SCREEN KIT (K831133) | Bionetic Laboratory Products | 1983-06-08 |
| LEGIONELLA DFA KIT I (K830820) | Bionetic Laboratory Products | 1983-06-08 |
| TESTCORP ANA (K831365) | Catheter Technology Corp. | 1983-06-02 |
| DISPOSABLE STERILE FILTER SYSTEM (K831450) | Corning Medical & Scientific | 1983-06-02 |
| API UNISCEPT PLUS AUTOINOCULATOR (K831341) | Analytical Products, Inc. | 1983-06-02 |
| AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (K830758) | Miles Laboratories, Inc. | 1983-05-25 |
| MYCOPLASMELISA TEST KIT (K823804) | M.A. Bioproducts | 1983-05-25 |
| BERA SH 221 BRIAN STEM AUDIOMETER (K830173) | Jedmed Instrument Co. | 1983-05-25 |
| API 20GP (K830525) | Analytical Products, Inc. | 1983-05-18 |
| MODIFIED NEW YORK MEDIUM (K831359) | Gibco Laboratories Life Technologies, Inc. | 1983-05-18 |
| TESTCORP ASO (K831363) | Catheter Technology Corp. | 1983-05-16 |
| STREPTOCOCUS ID PLATE (K831349) | Granite Diagnostics, Inc. | 1983-05-16 |
| TILL-U-TEST G.C. GONOCOCUS SLIDE (K831268) | Pasco Laboratories, Inc. | 1983-05-13 |
| MUMPSELISA TEST KIT (K830045) | M.A. Bioproducts | 1983-05-13 |
| CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE (K831219) | Gibco Laboratories Life Technologies, Inc. | 1983-05-13 |
| CLOSTRIDIUM DIFFICLE MEDIA (K831279) | Gibco Laboratories Life Technologies, Inc. | 1983-05-13 |
| CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP (K831179) | General Diagnostics | 1983-05-09 |
| RAPID NFT (K831186) | Dms Laboratories | 1983-05-09 |
| BIOCULT - GC CULTURE-PADDLES (K831124) | Orion Diagnostica, Inc. | 1983-05-09 |
| CYTOMEGELISA STAT (K830615) | M.A. Bioproducts | 1983-05-09 |
| TRP (K831187) | Dms Laboratories | 1983-05-09 |
| CLOSTRIDIUM DIFFICILE MEDIA (K831220) | Gibco Laboratories Life Technologies, Inc. | 1983-05-09 |
| CEFAXOLIN 30 MCG SENSI-DISC (K831153) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-05-09 |
| VARICELISA TEST KIT (K823805) | M.A. Bioproducts | 1983-05-05 |
| API ANAIDENT (K831032) | Analytical Products, Inc. | 1983-05-05 |
| LA-HISTO ANTIBODY SYSTEM #HL 1001 (K830837) | Immuno-Mycologics, Inc. | 1983-05-05 |
| CULUTURE SET CHLAMYDIA ISOLATION AND (K830342) | Immulok, Inc. | 1983-05-04 |
| ANAEROBE MIC/ID TEMPLATE, & TAXONOMY (K830964) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-05-04 |
| I/A KIT (K831159) | Staar Surgical Co. | 1983-04-28 |
| P & T MEDIUM (K831059) | American Micro Scan | 1983-04-28 |
| NETILMICIN 30MCG. SENSITIVITY DISCS (K830956) | Difco Laboratories, Inc. | 1983-04-27 |
| PHADEBACT STREP F TEST (K830445) | Pharmacia, Inc. | 1983-04-27 |
| THYMINE/THYMIDINE DISCS DDG (K830939) | Oxoid U.S.A., Inc. | 1983-04-13 |
| PEM-C (K830397) | Health Development Corp. | 1983-04-12 |
| NETILMICIN 30 MCG SENSI DISC (K830732) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-04-08 |
| VERI-STAPH (K830783) | Zeus Technologies | 1983-04-08 |
| ARTIMICROBIAL REMOVAL DEVICE (K830372) | Marion Laboratories, Inc. | 1983-04-08 |
| QUANTUM II BACTERIAL IDENT. SYSTEM (K830698) | Abbott Laboratories | 1983-04-08 |
| KNAI SODIUM POTASSIUM ANALYZER (K830805) | Radiometer America, Inc. | 1983-04-08 |
| NETILMICIN 30 MCG ANTIMICROBIAL DISK (K830731) | General Diagnostics | 1983-04-08 |
| YEAST IDENT (K830286) | Analytical Products, Inc. | 1983-04-05 |
| PEM-T (K830497) | Hedeco | 1983-04-05 |
| COMBION SKIN TEST (K830688) | Nicholas H. Maganias | 1983-03-31 |
| SECURET DRAPE & INSTRUMENT RETAINER/INCL (K830276) | Ritmed, Inc. | 1983-03-29 |
| C.A.T. REAGENT KIT (K830322) | Remel Co. | 1983-03-28 |
| BACTEC 170 TRYPTIC SOY BROTH W/RESINS (K830363) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-03-24 |
| API TB-IDENT* (K830211) | Analytical Products, Inc. | 1983-03-24 |
| CHS (K830437) | Dms Laboratories | 1983-03-17 |
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