The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for Dhea Test Set.
Device ID | K771793 |
510k Number | K771793 |
Device Name: | DHEA TEST SET |
Classification | Radioimmunoassay, Androsterone |
Applicant | WIEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIY |
CFR Regulation Number | 862.1080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-22 |
Decision Date | 1977-11-02 |