The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Syphilis Serological Reagents.
| Device ID | K871226 |
| 510k Number | K871226 |
| Device Name: | SYPHILIS SEROLOGICAL REAGENTS |
| Classification | Antigens, Nontreponemal, All |
| Applicant | NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Contact | Cynthia C Rohde |
| Correspondent | Cynthia C Rohde NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-27 |
| Decision Date | 1987-05-28 |