The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Centria Cortisol Ria Test Set.
Device ID | K792243 |
510k Number | K792243 |
Device Name: | CENTRIA CORTISOL RIA TEST SET |
Classification | Radioimmunoassay, Cortisol |
Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGR |
CFR Regulation Number | 862.1205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-07 |
Decision Date | 1979-12-06 |