VARELISA PR3 ANCA, MODEL NUMBER 17748/17796

Test System, Antineutrophil Cytoplasmic Antibodies (anca)

PHARMACIA DEUTSCHLAND GMBH

The following data is part of a premarket notification filed by Pharmacia Deutschland Gmbh with the FDA for Varelisa Pr3 Anca, Model Number 17748/17796.

Pre-market Notification Details

Device IDK041043
510k NumberK041043
Device Name:VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
ClassificationTest System, Antineutrophil Cytoplasmic Antibodies (anca)
Applicant PHARMACIA DEUTSCHLAND GMBH MUNZINGER STRASSE 7 Freiburg,  DE 79111
ContactMichael Linss
CorrespondentMichael Linss
PHARMACIA DEUTSCHLAND GMBH MUNZINGER STRASSE 7 Freiburg,  DE 79111
Product CodeMOB  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-22
Decision Date2004-07-02
Summary:summary

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