The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Cortisol Dsl 2000-sp.
| Device ID | K850141 |
| 510k Number | K850141 |
| Device Name: | ACTIVE CORTISOL DSL 2000-SP |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Gopal Savjani |
| Correspondent | Gopal Savjani DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-02-06 |