KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)

Starch-dye Bound Polymer, Amylase

EASTMAN KODAK COMPANY

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

Pre-market Notification Details

Device IDK812027
510k NumberK812027
Device Name:KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
ClassificationStarch-dye Bound Polymer, Amylase
Applicant EASTMAN KODAK COMPANY 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCIW  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-20
Decision Date1981-08-03

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