The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slides (li).
Device ID | K924488 |
510k Number | K924488 |
Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) |
Classification | Flame Photometry, Lithium |
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 | JIH |
CFR Regulation Number | 862.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-03 |
Decision Date | 1993-01-26 |