ADVIA CHEMISTRY GLUH_3 REAGENTS

Hexokinase, Glucose

Siemens Healthcare Diagnostics Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Chemistry Gluh_3 Reagents.

Pre-market Notification Details

Device IDK120681
510k NumberK120681
Device Name:ADVIA CHEMISTRY GLUH_3 REAGENTS
ClassificationHexokinase, Glucose
Applicant Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown,  NY  10509
ContactKira Gordon
CorrespondentKira Gordon
Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown,  NY  10509
Product CodeCFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-06
Decision Date2012-05-15
Summary:summary

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