Product code JSE
- Device name
- Culture Media, Multiple Biochemical Test
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2320
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962265 | MLX MICROTITER PLATE LUMINOMETER | Dynatech Laboratories, Inc. | 1996-07-25 |
| K883996 | X-ACT LDC/IND | Pro-Lab, Inc. | 1988-10-12 |
| K883995 | X-ACT UREA/TDA | Pro-Lab, Inc. | 1988-10-12 |
| K880133 | MIL MEDIUM | Hardy Media | 1988-03-31 |
| K880116 | MRVP BROTH | Hardy Media | 1988-03-31 |
| K874537 | KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR | Lakewood Biochemical Co., Inc. | 1987-11-20 |
| K871096 | CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES | bioMerieux, Inc. | 1987-04-03 |
| K864674 | MICRODILUTION IDENTIFICATION PANELS | American Micro Scan | 1987-01-05 |
| K862393 | BIOTIS LITMUS MILK | Otisville Biotech, Inc. | 1986-07-03 |
| K860412 | BIOTIS SIM MEDIUM | Otisville Biotech, Inc. | 1986-02-24 |
| K860413 | BIOTIS TSI | Otisville Biotech, Inc. | 1986-02-24 |
| K860414 | BIOTIS ORNITHINE INDOLE MOTILITY MEDIA | Otisville Biotech, Inc. | 1986-02-24 |
| K860415 | BIOTIS SIMMON CITRATE AGAR | Otisville Biotech, Inc. | 1986-02-24 |
| K860194 | AUSTIN ENTERIC SYSTEM | Austin Biological Laboratories | 1986-02-20 |
| K850982 | CTAPI - NEISSERA SCREEN | Analytical Products, Inc. | 1985-03-29 |
| K850734 | DIFFERENTIAL CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-20 |
| K850551 | SIM MEDIUM | Hardy Media | 1985-03-11 |
| K850548 | LYSINE IRON AGAR LIA | Hardy Media | 1985-03-11 |
| K850547 | MOTILITY INDOLE ORNITHINE AGAR | Hardy Media | 1985-03-11 |
| K850546 | KLIGLER IRON AGAR KIA | Hardy Media | 1985-03-11 |
| K843768 | BIOTIS KLIGLER IRON AGAR | Otisville Biotech, Inc. | 1984-10-10 |
| K842451 | RIM STREP KIT | Austin Biological Laboratories | 1984-07-02 |
| K842424 | BIOTIS LD-PRESUMPTO QUADRANT PLATE | Otisville Biotech, Inc. | 1984-07-02 |
| K841204 | MULTIPLE BIOCHEMICAL TEST | Smith River Biologicals | 1984-04-17 |
| K834003 | MOTILITY INDOLE ORNITHINE-MEDIUM | Micro Media Laboratories | 1983-12-22 |
| K834012 | SIM MEDIUM | Micro Media Laboratories | 1983-12-22 |
| K834004 | MYCOBIOTIC AGAR | Micro Media Laboratories | 1983-12-22 |
| K834002 | LYSINE IRON AGAR | Micro Media Laboratories | 1983-12-22 |
| K834001 | KLIGLER IRON AGAR | Micro Media Laboratories | 1983-12-22 |
| K832568 | INDOLE NITRATE MEDIUM | Acumedia Manufacturers, Inc. | 1983-09-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810144911076 | Redipor | AnalytiChem USA, Inc. | 2023-09-21 |
| 00819398026543 | N/A | HARDY DIAGNOSTICS | 2020-08-07 |
| 00819398026536 | N/A | HARDY DIAGNOSTICS | 2020-08-07 |
| 00819398026857 | N/A | HARDY DIAGNOSTICS | 2020-06-11 |
| 00819398023757 | N/A | HARDY DIAGNOSTICS | 2020-06-05 |
| 00819398022774 | N/A | HARDY DIAGNOSTICS | 2020-06-04 |
| 00819398022767 | N/A | HARDY DIAGNOSTICS | 2020-06-04 |
| 00819398020855 | N/A | HARDY DIAGNOSTICS | 2020-05-24 |
| 00819398020848 | N/A | HARDY DIAGNOSTICS | 2020-05-24 |
| 30382902982662 | BD BBL™ Motility lndole Lysine Sulfide Medium | BECTON, DICKINSON AND COMPANY | 2018-05-25 |