K000687 is an FDA 510(k) clearance for the THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST. This device is classified as a Antigens, Nontreponemal, All (Class II - Special Controls, product code GMQ).
Submitted by Beacon Biologicals, Inc. (Boca Raton, US). The FDA issued a Cleared decision on June 12, 2000, 104 days after receiving the submission on February 29, 2000.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3820.
| 510(k) Number | K000687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 2000 |
| Decision Date | June 12, 2000 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GMQ — Antigens, Nontreponemal, All |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3820 |