The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Free Thyroxine (ft4) Radioimmunoassay Kit.
| Device ID | K896222 |
| 510k Number | K896222 |
| Device Name: | FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
| Contact | Sandra Morris |
| Correspondent | Sandra Morris NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-30 |
| Decision Date | 1989-11-17 |