The following data is part of a premarket notification filed by Squibb & Sons, Inc. with the FDA for Estriol Ria Kit For Use With Gammaflo.
| Device ID | K801424 |
| 510k Number | K801424 |
| Device Name: | ESTRIOL RIA KIT FOR USE WITH GAMMAFLO |
| Classification | Radioimmunoassay, Estriol |
| Applicant | SQUIBB & SONS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CGI |
| CFR Regulation Number | 862.1265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-17 |
| Decision Date | 1980-07-21 |