K864981 is an FDA 510(k) clearance for the TOXOPLASMA GONDII. This device is classified as a Antigens, Cf, Toxoplasma Gondii (Class II - Special Controls, product code GMN).
Submitted by Virion (U.S.), Inc. (Morristown, US). The FDA issued a Cleared decision on October 30, 1987, 312 days after receiving the submission on December 22, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K864981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1986 |
| Decision Date | October 30, 1987 |
| Days to Decision | 312 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMN — Antigens, Cf, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |