The following data is part of a premarket notification filed by American Dade with the FDA for Stratus Cortisol Fluorometric Enzyme.
Device ID | K843183 |
510k Number | K843183 |
Device Name: | STRATUS CORTISOL FLUOROMETRIC ENZYME |
Classification | Radioimmunoassay, Cortisol |
Applicant | AMERICAN DADE 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 | 1984-08-13 |
Decision Date | 1984-09-17 |