The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Coralent Coat 125i Cortisol Radioimm..
Device ID | K791835 |
510k Number | K791835 |
Device Name: | CORALENT COAT 125I CORTISOL RADIOIMM. |
Classification | Radioimmunoassay, Cortisol |
Applicant | RADIOASSAY SYSTEMS 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 | 1979-09-17 |
Decision Date | 1979-09-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817830022306 | K791835 | 000 |