The following data is part of a premarket notification filed by Biotrax, Inc. with the FDA for Cromatest Rheumatoid Diagnostic/crp Latex Test.
| Device ID | K904497 |
| 510k Number | K904497 |
| Device Name: | CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST |
| Classification | System, Test, C-reactive Protein |
| 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 | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1990-11-01 |