The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for Gammadab [125] Fsh Radioimmunay Kit.
| Device ID | K821611 |
| 510k Number | K821611 |
| Device Name: | GAMMADAB [125] FSH RADIOIMMUNAY KIT |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | CLINICAL ASSAYS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-02 |
| Decision Date | 1982-06-24 |