The following data is part of a premarket notification filed by Canadian Bioclinical, Ltd. with the FDA for Digoxin/ria Kit Coated Tube Radioimmunoassay Kit.
| Device ID | K864449 |
| 510k Number | K864449 |
| Device Name: | DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. |
| 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 | DPO |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-12 |
| Decision Date | 1987-02-02 |