The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Dehydroepiandrosterone (dhea)(dsl 9000).
| Device ID | K935014 |
| 510k Number | K935014 |
| Device Name: | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) |
| Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| 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 | JKC |
| CFR Regulation Number | 862.1245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1994-05-09 |