The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Corti-shure.
| Device ID | K791700 |
| 510k Number | K791700 |
| Device Name: | CORTI-SHURE |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | NUCLEAR MEDICAL 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 | 1979-08-29 |
| Decision Date | 1979-10-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CORTI-SHURE 73285232 1236890 Dead/Cancelled |
Nuclear-Medical Laboratories, Inc. 1980-11-10 |