K883075 is an FDA 510(k) clearance for the FASTIDIOUS INOCULUM BROTH. This device is classified as a Culture Media, Selective Broth (Class I - General Controls, product code JSD).
Submitted by Baxter Healthcare Corp (West Sacramento, US). The FDA issued a Cleared decision on August 15, 1988, 33 days after receiving the submission on July 13, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K883075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1988 |
| Decision Date | August 15, 1988 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSD — Culture Media, Selective Broth |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2360 |