AMERLITE PROCESSING CENTER

Colorimeter, Photometer, Spectrophotometer For Clinical Use

EASTMAN KODAK COMPANY

The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Amerlite Processing Center.

Pre-market Notification Details

Device IDK915680
510k NumberK915680
Device Name:AMERLITE PROCESSING CENTER
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
ContactYvonne Adair
CorrespondentYvonne Adair
EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-19
Decision Date1992-03-11

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