The following data is part of a premarket notification filed by Canadian Bioclinical, Ltd. with the FDA for Cortisol-ria Kit Coated Tube Radioimmunoassay Kit.
| Device ID | K870969 |
| 510k Number | K870969 |
| Device Name: | CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | CANADIAN BIOCLINICAL, LTD. 81 FINCHDENE SQUARE, SCARBOROUGH Ontario Mix 1b4, CA |
| Contact | Dr. J Clapp |
| Correspondent | Dr. J Clapp CANADIAN BIOCLINICAL, LTD. 81 FINCHDENE SQUARE, SCARBOROUGH Ontario Mix 1b4, CA |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-10 |
| Decision Date | 1987-06-22 |