The following data is part of a premarket notification filed by American Dade with the FDA for Stratus Free Thyroxine (ft4) Fluor. Enzyme Immuno..
| Device ID | K870158 |
| 510k Number | K870158 |
| Device Name: | STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Karen H Darcy |
| Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-13 |
| Decision Date | 1987-03-19 |