GENCHEM ELECTROLYTE BUFFER

Electrode, Ion Specific, Sodium

GENCHEM, INC.

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

Pre-market Notification Details

Device IDK040977
510k NumberK040977
Device Name:GENCHEM ELECTROLYTE BUFFER
ClassificationElectrode, Ion Specific, Sodium
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 CodeJGS  
Subsequent Product CodeCEM
Subsequent Product CodeCGZ
Subsequent Product CodeJFL
Subsequent Product CodeJFP
CFR Regulation Number862.1665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-14
Decision Date2004-12-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851445007242 K040977 000

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