Product code JSK
- Device name
- Supplement, Culture Media
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2450
- 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 |
|---|---|---|---|
| K881949 | ATS NAC-PAC SET | Alpha-Tec Systems, Inc. | 1988-05-25 |
| K881879 | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | Alpha-Tec Systems, Inc. | 1988-05-13 |
| K881566 | HEMOGLOBIN POWDER | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K861997 | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | Hazleton Research Products, Inc. | 1986-06-10 |
| K861824 | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | Flow Laboratories, Inc. | 1986-05-20 |
| K861823 | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | Flow Laboratories, Inc. | 1986-05-20 |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | Flow Laboratories, Inc. | 1986-05-20 |
| K855172 | KWI (TM) G-CO/TWO | Micro-Bio-Logics | 1986-02-20 |
| K853546 | ABBOTT CATION SUPPLEMENT SOLUTION | Abbott Laboratories | 1985-09-06 |
| K850302 | SUPLEX & SUPLEX DILUENT | Pro-Lab, Inc. | 1985-03-22 |
| K850301 | YEAST DIALYSATE | Pro-Lab, Inc. | 1985-03-20 |
| K850299 | C.N.V.T. | Pro-Lab, Inc. | 1985-03-20 |
| K850300 | MUCOLYSE | Pro-Lab, Inc. | 1985-03-20 |
| K850307 | CAMPYLOBACTER SUPPLEMENT-BLASER/WANG | Pro-Lab, Inc. | 1985-03-20 |
| K850308 | C.L.A.T. | Pro-Lab, Inc. | 1985-03-20 |
| K850738 | SUPPLEMENT FOR CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-20 |
| K850306 | CAMPYLOBACTER SUPPLEMENT -SKIRROW | Pro-Lab, Inc. | 1985-03-20 |
| K840333 | LEGIONELLA BMPA SELECTIVE SUPPLE | Oxoid U.S.A., Inc. | 1984-05-11 |
| K840330 | PRESTON CAMPYLOBACTER SELECTIVE SUPP | Oxoid U.S.A., Inc. | 1984-05-11 |
| K840331 | LEGIONELLA MWY SELECTIVE SUPPLEMENT | Oxoid U.S.A., Inc. | 1984-05-11 |
| K834115 | CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-23 |
| K834066 | TINSDALE ENRICHMENT | Remel Co. | 1984-01-04 |
| K833210 | LACTOSE | Acumedia Manufacturers, Inc. | 1983-10-27 |
| K833019 | CAMPYLOBACTER SELECTIVE SUPPLE-BLASER | Gibco Laboratories Life Technologies, Inc. | 1983-10-14 |
| K833018 | CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW | Gibco Laboratories Life Technologies, Inc. | 1983-10-14 |
| K833020 | CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER | Gibco Laboratories Life Technologies, Inc. | 1983-10-14 |
| K832902 | MIDDLEBROOK ADC ENRICHMENT | Gibco Laboratories Life Technologies, Inc. | 1983-09-26 |
| K831469 | LEGIONELLA CYE AGAR BASE & BCYE SUPPL | Oxoid U.S.A., Inc. | 1983-06-08 |
| K831219 | CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE | Gibco Laboratories Life Technologies, Inc. | 1983-05-13 |
| K820610 | GELRITE | Kelco | 1982-10-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20628429001008 | Mucolyse (10x100 mg) | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001001 | Mucolyse (Inner-100 mg) | PRO-LAB, INCORPORATED | 2022-12-25 |
| 00816085024073 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00816085020921 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00816085020938 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00816085020945 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00816085020952 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00816085020969 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00816085020976 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00816085020983 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00816085020990 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00816085022406 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085021850 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085021614 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085021317 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085020631 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085021522 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085024066 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085023359 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085023298 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085023199 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085023182 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085023175 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085023151 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085023120 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816085022925 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-09 |
| 00816576028955 | N/A | HARDY DIAGNOSTICS | 2020-08-12 |
| 00819398026390 | N/A | HARDY DIAGNOSTICS | 2020-06-16 |
| 00819398024563 | N/A | HARDY DIAGNOSTICS | 2020-06-08 |
| 00819398023986 | N/A | HARDY DIAGNOSTICS | 2020-06-05 |