The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Amerlite Mab Ft4 Assay.
Device ID | K920247 |
510k Number | K920247 |
Device Name: | AMERLITE MAB FT4 ASSAY |
Classification | Radioimmunoassay, Free Thyroxine |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Yvonne Adair |
Correspondent | Yvonne Adair EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | CEC |
CFR Regulation Number | 862.1695 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-21 |
Decision Date | 1992-03-02 |