CALCIUM, AZO DYE REAGENT

Azo Dye, Calcium

GENCHEM, INC.

The following data is part of a premarket notification filed by Genchem, Inc. with the FDA for Calcium, Azo Dye Reagent.

Pre-market Notification Details

Device IDK040972
510k NumberK040972
Device Name:CALCIUM, AZO DYE REAGENT
ClassificationAzo Dye, Calcium
Applicant GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 Brea,  CA  92821
ContactC.c. Allain
CorrespondentC.c. Allain
GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 Brea,  CA  92821
Product CodeCJY  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-14
Decision Date2004-12-27
Summary:summary

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