510(k) K902356

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) by Eastman Kodak Company — Product Code DKJ

K902356 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)". The FDA issued a decision of Substantially Equivalent on July 16, 1990. The device falls under product code DKJ (Colorimetry, Salicylate), a Class II device regulated under 21 CFR 862.3830. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1990
Date Received
May 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Salicylate
Device Class
Class II
Regulation Number
862.3830
Review Panel
TX
Submission Type