510(k) DEN140010

PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM by Wallac OY — Product Code PJI

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 15, 2014
Date Received: February 19, 2014
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Device Class: Class II
Regulation Number: 866.5930
Review Panel: IM
Submission Type

A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).

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510(k) DEN140010

Clearance Details

Device Classification

Other clearances by Wallac OY

Other clearances for product code PJI