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PQW — Alpha-D-Galactosidase A (Gla) Newborn Screening Test System Class II

FDA Device Classification

Classification Details

Product Code
PQW
Device Class
Class II
Regulation Number
862.1488
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Definition

For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K190266perkinelmerNeoLSD MSMS KitMay 3, 2019
K173829wallac oy, a subsidiary of perkinelmerNeoLSD MSMS kitJuly 18, 2018
DEN150035baebiesSEEKER SystemFebruary 3, 2017