The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Phase Ii Cortisol Kit.
Device ID | K834219 |
510k Number | K834219 |
Device Name: | PHASE II CORTISOL KIT |
Classification | Radioimmunoassay, Cortisol |
Applicant | MEDICAL & SCIENTIFIC DESIGNS, 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 | 1983-12-05 |
Decision Date | 1984-02-04 |