The following data is part of a premarket notification filed by E. R. Squibb & Sons, Inc. with the FDA for Cortisol-squibb Radioimmunoassay Kit.
| Device ID | K820341 |
| 510k Number | K820341 |
| Device Name: | CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York, NY 10019 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-08 |
| Decision Date | 1982-03-04 |