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 |