The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slides (nail).
Device ID | K924471 |
510k Number | K924471 |
Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL) |
Classification | Electrode, Ion Specific, Sodium |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Yvonne E Adair |
Correspondent | Yvonne E Adair EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | JGS |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-02 |
Decision Date | 1992-11-06 |