The following data is part of a premarket notification filed by Sero-immuno Diagnostics, Inc. with the FDA for Dat Test For Chagas' Disease.
| Device ID | K834328 |
| 510k Number | K834328 |
| Device Name: | DAT TEST FOR CHAGAS' DISEASE |
| Classification | Antigen, Latex Agglutination, T. Cruzi |
| Applicant | SERO-IMMUNO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GNE |
| CFR Regulation Number | 866.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-09 |
| Decision Date | 1984-03-02 |