JSE
53 FDA 510(k) clearances · Product code
26 daysmedian time to decision
43 days90th percentile
53clearances measured
FDA profile
- Official device name
- Culture Media, Multiple Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MLX MICROTITER PLATE LUMINOMETER (K962265) | Dynatech Laboratories, Inc. | 1996-07-25 |
| X-ACT LDC/IND (K883996) | Pro-Lab, Inc. | 1988-10-12 |
| X-ACT UREA/TDA (K883995) | Pro-Lab, Inc. | 1988-10-12 |
| MRVP BROTH (K880116) | Hardy Media | 1988-03-31 |
| MIL MEDIUM (K880133) | Hardy Media | 1988-03-31 |
| KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (K874537) | Lakewood Biochemical Co., Inc. | 1987-11-20 |
| CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES (K871096) | bioMerieux, Inc. | 1987-04-03 |
| MICRODILUTION IDENTIFICATION PANELS (K864674) | American Micro Scan | 1987-01-05 |
| BIOTIS LITMUS MILK (K862393) | Otisville Biotech, Inc. | 1986-07-03 |
| BIOTIS TSI (K860413) | Otisville Biotech, Inc. | 1986-02-24 |
| BIOTIS ORNITHINE INDOLE MOTILITY MEDIA (K860414) | Otisville Biotech, Inc. | 1986-02-24 |
| BIOTIS SIM MEDIUM (K860412) | Otisville Biotech, Inc. | 1986-02-24 |
| BIOTIS SIMMON CITRATE AGAR (K860415) | Otisville Biotech, Inc. | 1986-02-24 |
| AUSTIN ENTERIC SYSTEM (K860194) | Austin Biological Laboratories | 1986-02-20 |
| CTAPI - NEISSERA SCREEN (K850982) | Analytical Products, Inc. | 1985-03-29 |
| DIFFERENTIAL CULTURE MEDIUM (K850734) | Roseville Medical Laboratoriesu | 1985-03-20 |
| KLIGLER IRON AGAR KIA (K850546) | Hardy Media | 1985-03-11 |
| LYSINE IRON AGAR LIA (K850548) | Hardy Media | 1985-03-11 |
| SIM MEDIUM (K850551) | Hardy Media | 1985-03-11 |
| MOTILITY INDOLE ORNITHINE AGAR (K850547) | Hardy Media | 1985-03-11 |
| BIOTIS KLIGLER IRON AGAR (K843768) | Otisville Biotech, Inc. | 1984-10-10 |
| BIOTIS LD-PRESUMPTO QUADRANT PLATE (K842424) | Otisville Biotech, Inc. | 1984-07-02 |
| RIM STREP KIT (K842451) | Austin Biological Laboratories | 1984-07-02 |
| MULTIPLE BIOCHEMICAL TEST (K841204) | Smith River Biologicals | 1984-04-17 |
| MOTILITY INDOLE ORNITHINE-MEDIUM (K834003) | Micro Media Laboratories | 1983-12-22 |
| KLIGLER IRON AGAR (K834001) | Micro Media Laboratories | 1983-12-22 |
| LYSINE IRON AGAR (K834002) | Micro Media Laboratories | 1983-12-22 |
| MYCOBIOTIC AGAR (K834004) | Micro Media Laboratories | 1983-12-22 |
| SIM MEDIUM (K834012) | Micro Media Laboratories | 1983-12-22 |
| INDOLE NITRATE MEDIUM (K832568) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| API 20GP (K830525) | Analytical Products, Inc. | 1983-05-18 |
| CHRISTENSENS CITRATE SULFIDE AGAR (K822998) | Granite Diagnostics, Inc. | 1982-11-16 |
| LECITHIN LACTOSE AGAR (K823072) | Granite Diagnostics, Inc. | 1982-11-05 |
| TRIPLE SUGAR IRON AGAR SLANT (K821592) | Hardy Media | 1982-07-08 |
| CULTURE MEDIA, NON-SELECTIVE/DIFFER (K820842) | Blue Ridge Media Co. | 1982-04-16 |
| CULTURE MEDIA, MULTIPLE BIOCHEMICAL (K820841) | Blue Ridge Media Co. | 1982-04-16 |
| #4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE (K820810) | Biomedica, Inc. | 1982-04-08 |
| SUCROSE (K820214) | Dms Laboratories | 1982-02-05 |
| BCYE MEDIUM (K812911) | Gibco Laboratories Life Technologies, Inc. | 1981-11-06 |
| PGUA-INDOL MICROTUBE (K812467) | Carr Microbiologicals | 1981-09-14 |
| ONPX-INDOL MEDIUM MICROTUBES (K812466) | Carr Microbiologicals | 1981-09-14 |
| RAPID FERMENTATION AGAR (RFA) (K800734) | Remel Co. | 1980-05-08 |
| SIM MEDIUM (K792420) | Isle Media and Sterile Products, Inc. | 1979-12-31 |
| DECARBOXYLASE MOELLER BASE WITH OR WITH- (K792425) | Isle Media and Sterile Products, Inc. | 1979-12-27 |
| API 20E REAGENT QC (K791222) | Analytical Products, Inc. | 1979-08-22 |
| TRIPLE SUGAR IRON AGAR (TSI AGAR) (K791473) | Isle Media and Sterile Products, Inc. | 1979-08-22 |
| CARBOHYDRATE FERMENTATION MEDIA (K790617) | Anaerobe Systems | 1979-04-23 |
| DENTRIFICATION LACTOSE AGAR (K790230) | Los Angeles Biological Products | 1979-02-21 |
| AGAR, MOTILITY-NITRATE (K790232) | Los Angeles Biological Products | 1979-02-21 |
| PLATE, LD PRESUMPTO (K781856) | Anaerobe Systems | 1978-11-22 |
| API 50 E (K770989) | Analytical Products, Inc. | 1977-06-29 |
| PANEL, IDENTIFICATION, STREP, MICRO-ID (K770746) | Micro-Media Systems, Inc. | 1977-06-23 |
| API 3S (K770176) | Analytical Products, Inc. | 1977-02-18 |
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