The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl 1020.
| Device ID | K821068 |
| 510k Number | K821068 |
| Device Name: | DSL 1020 |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 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 | 1982-04-16 |
| Decision Date | 1982-05-05 |