The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Tipsep-cortisol Ria Diagnostic Kit.
| Device ID | K872177 |
| 510k Number | K872177 |
| Device Name: | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy, MI 48083 |
| Contact | Cindy A Wenzlick |
| Correspondent | Cindy A Wenzlick NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy, MI 48083 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-08 |
| Decision Date | 1987-06-17 |