K842664 is an FDA 510(k) clearance for the ANTI-TOXOPLASMA GONDII KIT. This device is classified as a Antigens, If, Toxoplasma Gondii (Class II - Special Controls, product code GLZ).
Submitted by Amico Lab, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984, 49 days after receiving the submission on July 10, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K842664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1984 |
| Decision Date | August 28, 1984 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GLZ — Antigens, If, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |