K791571 is an FDA 510(k) clearance for the TOXOPLASMA ANTIBODY TEST SYSTEM. This device is classified as a Antigens, If, Toxoplasma Gondii (Class II - Special Controls, product code GLZ).
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1979, 42 days after receiving the submission on August 13, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K791571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1979 |
| Decision Date | September 24, 1979 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GLZ — Antigens, If, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |