GENCHEM ISE ELECTROLYTE REFERENCE

Electrode, Ion Specific, Sodium

GENCHEM, INC.

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

Pre-market Notification Details

Device IDK040971
510k NumberK040971
Device Name:GENCHEM ISE ELECTROLYTE REFERENCE
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 Date2004-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851445007259 K040971 000

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