GSP NEONATAL BIOTINIDASE KIT

System, Test, Biotinidase

WALLAC OY

The following data is part of a premarket notification filed by Wallac Oy with the FDA for Gsp Neonatal Biotinidase Kit.

Pre-market Notification Details

Device IDK131284
510k NumberK131284
Device Name:GSP NEONATAL BIOTINIDASE KIT
ClassificationSystem, Test, Biotinidase
Applicant WALLAC OY 940 WINTER STREET Waltham,  MA  02451
ContactJeanette Schier-pugsley
CorrespondentJeanette Schier-pugsley
WALLAC OY 940 WINTER STREET Waltham,  MA  02451
Product CodeNAK  
CFR Regulation Number862.1118 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-06
Decision Date2013-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147330911 K131284 000

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