VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696

System, Test, Anticardiolipin Immunological

PHARMACIA DEUTSCHLAND GMBH

The following data is part of a premarket notification filed by Pharmacia Deutschland Gmbh with the FDA for Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696.

Pre-market Notification Details

Device IDK020758
510k NumberK020758
Device Name:VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant PHARMACIA DEUTSCHLAND GMBH MUNZINGERSTRASSE 7 Freiburg,  DE
ContactMicharl Linss
CorrespondentMicharl Linss
PHARMACIA DEUTSCHLAND GMBH MUNZINGERSTRASSE 7 Freiburg,  DE
Product CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-07
Decision Date2002-05-02
Summary:summary

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