K830065 is an FDA 510(k) clearance for the SALMONELLA-SHIGELLA AGAR. This device is classified as a Culture Media, Selective And Differential (Class I - General Controls, product code JSI).
Submitted by bioMerieux, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1983, 30 days after receiving the submission on January 11, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K830065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1983 |
| Decision Date | February 10, 1983 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JSI — Culture Media, Selective And Differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2360 |