The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for Ria Kit, Gammacoat.
| Device ID | K782109 |
| 510k Number | K782109 |
| Device Name: | RIA KIT, GAMMACOAT |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | CLINICAL ASSAYS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-19 |
| Decision Date | 1979-01-26 |