K822799 is an FDA 510(k) clearance for the STREPTACOCCUS CO-AGGLUTINATION KIT. This device is classified as a Exoenzymes, Multiple, Streptococcal (Class I - General Controls, product code GTP).
Submitted by American Scientific Products (Walker, US). The FDA issued a Cleared decision on December 19, 1982, 94 days after receiving the submission on September 16, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3720.
| 510(k) Number | K822799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 1982 |
| Decision Date | December 19, 1982 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTP — Exoenzymes, Multiple, Streptococcal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3720 |