KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)

Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

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 Slide Alcohol (alc).

Pre-market Notification Details

Device IDK934273
510k NumberK934273
Device Name:KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
ClassificationEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Applicant EASTMAN KODAK COMPANY 100 INDIGO CREEK DR. Rochester,  NY  14652 -0882
ContactYvonne E Middlefell
CorrespondentYvonne E Middlefell
EASTMAN KODAK COMPANY 100 INDIGO CREEK DR. Rochester,  NY  14652 -0882
Product CodeDMT  
CFR Regulation Number862.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-31
Decision Date1994-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.