KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)

Enzyme Immunoassay, Theophylline

EASTMAN KODAK COMPANY

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

Pre-market Notification Details

Device IDK861367
510k NumberK861367
Device Name:KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
ClassificationEnzyme Immunoassay, Theophylline
Applicant EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
ContactPhilip J Harter
CorrespondentPhilip J Harter
EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
Product CodeKLS  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-11
Decision Date1986-05-29

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