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510(k) K173829

NeoLSD MSMS kit by Wallac Oy, A Subsidiary of Perkinelmer — Product Code PQW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 18, 2018
Date Received: December 18, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Device Class: Class II
Regulation Number: 862.1488
Review Panel: CH
Submission Type

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