The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for Coritsol Premix Ria Kit.
| Device ID | K842957 |
| 510k Number | K842957 |
| Device Name: | CORITSOL PREMIX RIA KIT |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | BIOTECX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-27 |
| Decision Date | 1984-09-14 |