K850591 is an FDA 510(k) clearance for the FIAX TOXO-M ANTIBODIES TEST KIT. This device is classified as a Antigens, If, Toxoplasma Gondii (Class II - Special Controls, product code GLZ).
Submitted by Intl. Diagnostic Technology (San Jose, US). The FDA issued a Cleared decision on April 30, 1985, 75 days after receiving the submission on February 14, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K850591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1985 |
| Decision Date | April 30, 1985 |
| Days to Decision | 75 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 |