K924882 is an FDA 510(k) clearance for the TOXOPLASMA IGM IFA TEST SYSTEM. This device is classified as a Antigens, If, Toxoplasma Gondii (Class II - Special Controls, product code GLZ).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on March 23, 1993, 176 days after receiving the submission on September 28, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K924882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1992 |
| Decision Date | March 23, 1993 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GLZ — Antigens, If, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |