SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

Test, Qualitative And Quantitative Factor Deficiency

SHIELD DIAGNOSTICS, LTD.

The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Shield Von Willebrand Factor Activity Elisa, Model Fvwf 200.

Pre-market Notification Details

Device IDK000398
510k NumberK000398
Device Name:SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee,  GB Dd2 1sw
ContactEileen Mccafferty
CorrespondentEileen Mccafferty
SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee,  GB Dd2 1sw
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-07
Decision Date2000-04-17

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