CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

Autoantibodies, Endomysial(tissue Transglutaminase)

SWEDEN DIAGNOSTICS (GERMANY) GMBH

The following data is part of a premarket notification filed by Sweden Diagnostics (germany) Gmbh with the FDA for Celikey Ttg (human, Recombinant) Iga Antibodies Model #18148/18196.

Pre-market Notification Details

Device IDK041174
510k NumberK041174
Device Name:CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
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 CodeMVM  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-05
Decision Date2004-07-19
Summary:summary

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