The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rpr Test Reditest.
| Device ID | K843741 |
| 510k Number | K843741 |
| Device Name: | RPR TEST REDITEST |
| Classification | Antisera, Control For Nontreponemal Tests |
| Applicant | BIOKIT USA, INC. CORCEGA 603-605 08025 Barcelona, Spain , |
| Contact | Angeles Rodriquez |
| Correspondent | Angeles Rodriquez BIOKIT USA, INC. CORCEGA 603-605 08025 Barcelona, Spain , |
| Product Code | GMP |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-25 |
| Decision Date | 1984-10-25 |