ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS

Calibrator, Multi-analyte Mixture

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 Liquid Specific Protein Calibrators.

Pre-market Notification Details

Device IDK103701
510k NumberK103701
Device Name:ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
ClassificationCalibrator, Multi-analyte Mixture
Applicant SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown,  NY  10591
ContactKira Gordon
CorrespondentKira Gordon
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown,  NY  10591
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-20
Decision Date2011-02-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414597553 K103701 000
00630414482453 K103701 000

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