VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996

System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

PHARMACIA DEUTSCHLAND GMBH

The following data is part of a premarket notification filed by Pharmacia Deutschland Gmbh with the FDA for Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 And 18996.

Pre-market Notification Details

Device IDK040450
510k NumberK040450
Device Name:VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
ClassificationSystem,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Applicant PHARMACIA DEUTSCHLAND GMBH DIAGNOSTICS DIVISION MUNZINGER STRASSE 7 Freiburg,  DE D-79111
ContactMichael Linss
CorrespondentMichael Linss
PHARMACIA DEUTSCHLAND GMBH DIAGNOSTICS DIVISION MUNZINGER STRASSE 7 Freiburg,  DE D-79111
Product CodeMSV  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-20
Decision Date2004-05-11
Summary:summary

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