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510(k) K190266

NeoLSD MSMS Kit by Perkinelmer, Inc. — Product Code PQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2019
Date Received
February 8, 2019
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.

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Other clearances for product code PQW

  • K173829 — NeoLSD MSMS kit (July 18, 2018)
  • DEN150035 — SEEKER System (February 3, 2017)