The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active Aldosterone (dsl 8600).
| Device ID | K921205 |
| 510k Number | K921205 |
| Device Name: | DSL ACTIVE ALDOSTERONE (DSL 8600) |
| Classification | Radioimmunoassay, Aldosterone |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Johnny R Willis |
| Correspondent | Johnny R Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | CJM |
| CFR Regulation Number | 862.1045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-12 |
| Decision Date | 1992-07-10 |