The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dhea-sulfate I Ria Kit.
Device ID | K832154 |
510k Number | K832154 |
Device Name: | DHEA-SULFATE I RIA KIT |
Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JKC |
CFR Regulation Number | 862.1245 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-05 |
Decision Date | 1983-08-16 |