The following data is part of a premarket notification filed by Cyberfluor, Inc. with the FDA for Fiagen Tbg Time-resolved Fluoroimmunoassay Kit.
| Device ID | K884201 |
| 510k Number | K884201 |
| Device Name: | FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| Applicant | CYBERFLUOR, INC. 179 JOHN ST., 4TH FL., TORONTO Ontario M5t 1x4, CA |
| Contact | James Clelland |
| Correspondent | James Clelland CYBERFLUOR, INC. 179 JOHN ST., 4TH FL., TORONTO Ontario M5t 1x4, CA |
| Product Code | CEE |
| CFR Regulation Number | 862.1685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1988-12-14 |