The following data is part of a premarket notification filed by Serono Laboratories, Inc. with the FDA for Estriol Radioimmunoassay Test Kit.
| Device ID | K810695 |
| 510k Number | K810695 |
| Device Name: | ESTRIOL RADIOIMMUNOASSAY TEST KIT |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | SERONO LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-16 |
| Decision Date | 1981-03-31 |