K830078 is an FDA 510(k) clearance for the BLOOD AGAR(TSA W/5% SHEEP BLOOD). This device is classified as a Culture Media, Enriched (Class I - General Controls, product code KZI).
Submitted by bioMerieux, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1983, 29 days after receiving the submission on January 11, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.2330.
| 510(k) Number | K830078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1983 |
| Decision Date | February 09, 1983 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | KZI — Culture Media, Enriched |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2330 |