The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active Aldosterone Ria (dsl 8600).
| Device ID | K943397 |
| 510k Number | K943397 |
| Device Name: | DSL ACTIVE ALDOSTERONE RIA (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 | 1994-07-14 |
| Decision Date | 1995-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590211592 | K943397 | 000 |