The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Chemelia Free Thyroxine(ft4)/enzyme Immuno. (eia).
| Device ID | K874875 |
| 510k Number | K874875 |
| Device Name: | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. 1 SOUTH RIDGEDALE AVE. East Hanover, NJ 07936 |
| Contact | John Simpson |
| Correspondent | John Simpson BOOTS-CELLTECH DIAGNOSTICS, INC. 1 SOUTH RIDGEDALE AVE. East Hanover, NJ 07936 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-27 |
| Decision Date | 1988-03-24 |