The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Synthetic Vdrl Antigen.
| Device ID | K993633 |
| 510k Number | K993633 |
| Device Name: | SYNTHETIC VDRL ANTIGEN |
| Classification | Antigens, Nontreponemal, All |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. Atlanta, GA 30333 |
| Contact | Victoria Pope |
| Correspondent | Victoria Pope CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. Atlanta, GA 30333 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-27 |
| Decision Date | 2000-02-23 |