GENCHEM CREATININE REAGENT

Alkaline Picrate, Colorimetry, Creatinine

GENCHEM, INC.

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

Pre-market Notification Details

Device IDK040976
510k NumberK040976
Device Name:GENCHEM CREATININE REAGENT
ClassificationAlkaline Picrate, Colorimetry, Creatinine
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 CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-14
Decision Date2004-12-27
Summary:summary

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