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510(k) DEN180056

GSP Neonatal Creatine Kinase - MM kit by Perkinelmer, Inc. — Product Code QJE

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 12, 2019
Date Received
October 11, 2018
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Muscular Dystrophy Newborn Screening Test
Device Class
Class II
Regulation Number
862.1506
Review Panel
CH
Submission Type

A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy.

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