The following data is part of a premarket notification filed by Beacon Biologicals, Inc. with the FDA for The Daya Syphilis Test/the Trust Antigen Test.
| Device ID | K000687 |
| 510k Number | K000687 |
| Device Name: | THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST |
| Classification | Antigens, Nontreponemal, All |
| Applicant | BEACON BIOLOGICALS, INC. 6004 GLENDALE DR. Boca Raton, FL 33433 |
| Contact | Kanti Daya |
| Correspondent | Kanti Daya BEACON BIOLOGICALS, INC. 6004 GLENDALE DR. Boca Raton, FL 33433 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-29 |
| Decision Date | 2000-06-12 |