GSP NEONATAL TOTAL GALACTOSE KIT

Enzymatic Methods, Galactose

WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.

The following data is part of a premarket notification filed by Wallac Oy, A Subsidiary Of Perkinelmer, Inc. with the FDA for Gsp Neonatal Total Galactose Kit.

Pre-market Notification Details

Device IDK133652
510k NumberK133652
Device Name:GSP NEONATAL TOTAL GALACTOSE KIT
ClassificationEnzymatic Methods, Galactose
Applicant WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. 940 WINTER STREET Waltham,  MA  02451
ContactJeanette Schier-pugsley
CorrespondentJeanette Schier-pugsley
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. 940 WINTER STREET Waltham,  MA  02451
Product CodeJIA  
CFR Regulation Number862.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-27
Decision Date2014-04-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147328031 K133652 000

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