The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Micromedic Estriol Ria Kit.
| Device ID | K822578 |
| 510k Number | K822578 |
| Device Name: | MICROMEDIC ESTRIOL RIA KIT |
| Classification | Radioimmunoassay, Estriol |
| Applicant | MICROMEDIC SYSTEMS 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 | 1982-08-25 |
| Decision Date | 1982-10-26 |