CA BUFFER CA DYE

Cresolphthalein Complexone, Calcium

ALPKEM CORP.

The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Ca Buffer Ca Dye.

Pre-market Notification Details

Device IDK852002
510k NumberK852002
Device Name:CA BUFFER CA DYE
ClassificationCresolphthalein Complexone, Calcium
Applicant ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
ContactYosip F Warda
CorrespondentYosip F Warda
ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
Product CodeCIC  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-07
Decision Date1985-06-25

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