GENCHEM CO2 ACID REAGENT

Ph Rate Measurement, Carbon-dioxide

GENCHEM, INC.

The following data is part of a premarket notification filed by Genchem, Inc. with the FDA for Genchem Co2 Acid Reagent.

Pre-market Notification Details

Device IDK040975
510k NumberK040975
Device Name:GENCHEM CO2 ACID REAGENT
ClassificationPh Rate Measurement, Carbon-dioxide
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 CodeJFL  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-14
Decision Date2004-12-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851445007167 K040975 000
00851445007150 K040975 000

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