K981263 is an FDA 510(k) clearance for the TOXOGEN. This device is classified as a Antigens, Iha, Toxoplasma Gondii (Class II - Special Controls, product code GMM).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 6, 1998, 121 days after receiving the submission on April 7, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K981263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1998 |
| Decision Date | August 06, 1998 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GMM — Antigens, Iha, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |