VARELISA RECOMBI CTD SCREEN, MODEL 13096

Antinuclear Antibody (enzyme-labeled), Antigen, Controls

SWEDEN DIAGNOSTICS (GERMANY) GMBH

The following data is part of a premarket notification filed by Sweden Diagnostics (germany) Gmbh with the FDA for Varelisa Recombi Ctd Screen, Model 13096.

Pre-market Notification Details

Device IDK050967
510k NumberK050967
Device Name:VARELISA RECOMBI CTD SCREEN, MODEL 13096
ClassificationAntinuclear Antibody (enzyme-labeled), Antigen, Controls
Applicant SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7 Freiburg,  DE D-79111
ContactMichael Linss
CorrespondentMichael Linss
SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7 Freiburg,  DE D-79111
Product CodeLJM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-18
Decision Date2005-06-28
Summary:summary

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