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 |