The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Dhea-sulfate Dsl3500.
Device ID | K851239 |
510k Number | K851239 |
Device Name: | ACTIVE DHEA-SULFATE DSL3500 |
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 | 1985-03-27 |
Decision Date | 1985-04-25 |