K851977 is an FDA 510(k) clearance for the HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT. This device is classified as a Antigens, Iha, Toxoplasma Gondii (Class II - Special Controls, product code GMM).
Submitted by Si Sero-Immuno Diagnostics, Inc. (Tucker, US). The FDA issued a Cleared decision on October 16, 1985, 162 days after receiving the submission on May 7, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K851977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1985 |
| Decision Date | October 16, 1985 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMM — Antigens, Iha, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |