The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slides (sali).
Device ID | K902356 |
510k Number | K902356 |
Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) |
Classification | Colorimetry, Salicylate |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Karen Warren |
Correspondent | Karen Warren EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | DKJ |
CFR Regulation Number | 862.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-29 |
Decision Date | 1990-07-16 |