The following data is part of a premarket notification filed by Diagnostics Biochem Canada, Inc. with the FDA for Estrone Analysis Products Radioimmunoassay Estrone.
| Device ID | K864966 |
| 510k Number | K864966 |
| Device Name: | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE |
| Classification | Radioimmunoassay, Estrone |
| Applicant | DIAGNOSTICS BIOCHEM CANADA, INC. 1020 HARGRIEVE RD. London, Ontario, CA N6e 1p5 |
| Product Code | CGF |
| CFR Regulation Number | 862.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-01-09 |