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510(k) DEN150035

SEEKER System by Baebies, Inc. — Product Code PQW

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: February 3, 2017
Date Received: August 5, 2015
Clearance Type: Direct
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.