The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Cortisol125 Radioimmunoassay.
Device ID | K802036 |
510k Number | K802036 |
Device Name: | CORTISOL125 RADIOIMMUNOASSAY |
Classification | Radioimmunoassay, Cortisol |
Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1980-08-22 |
Decision Date | 1980-10-23 |