The following data is part of a premarket notification filed by Biotrax, Inc. with the FDA for Croatest (r) Rheumatoid Diagnostic.
| Device ID | K904416 |
| 510k Number | K904416 |
| Device Name: | CROATEST (R) RHEUMATOID DIAGNOSTIC |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | BIOTRAX, INC. 5202 WESTLAND BLVD. Baltimore, MD 21227 |
| Contact | Santo L Grillo |
| Correspondent | Santo L Grillo BIOTRAX, INC. 5202 WESTLAND BLVD. Baltimore, MD 21227 |
| Product Code | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-27 |
| Decision Date | 1991-06-24 |