The following data is part of a premarket notification filed by Biotrax, Inc. with the FDA for Cromatest Syphilis Diagnostic.
| Device ID | K904496 |
| 510k Number | K904496 |
| Device Name: | CROMATEST SYPHILIS DIAGNOSTIC |
| Classification | Antigens, Nontreponemal, All |
| Applicant | BIOTRAX, INC. 5202 WESTLAND BLVD. Baltimore, MD 21227 |
| Contact | Santo Grillo |
| Correspondent | Santo Grillo BIOTRAX, INC. 5202 WESTLAND BLVD. Baltimore, MD 21227 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1991-07-24 |