KODAK EKTACHEM DT SLIDES (CHE)

Colorimetry, Cholinesterase

EASTMAN KODAK COMPANY

The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Dt Slides (che).

Pre-market Notification Details

Device IDK913198
510k NumberK913198
Device Name:KODAK EKTACHEM DT SLIDES (CHE)
ClassificationColorimetry, Cholinesterase
Applicant EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
ContactNorman H Geil
CorrespondentNorman H Geil
EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
Product CodeDIH  
CFR Regulation Number862.3240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-18
Decision Date1991-08-26

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