The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Cortisol Kit.
| Device ID | K810192 |
| 510k Number | K810192 |
| Device Name: | ENDAB CORTISOL KIT |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | IMMUNOTECH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-23 |
| Decision Date | 1981-02-06 |