510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140010Unknown

Perkinelmer Enlite Neonatal Trec Test System

Wallac Oy, Waltham MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN140010 is the FDA 510(k) clearance record for PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM, a class II device, cleared for Wallac OY on under FDA product code PJI (Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System). FDA's definition for product code PJI reads: "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...". FDA records list 24 510(k) clearances for Wallac OY, from to . As of , FDA records show no recalls naming DEN140010.

Clearance record

Decision date
Received
(299 days to decision)
Product code
PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Regulation
21 CFR 866.5930
Device class
Class II
Review panel
Immunology
Applicant
Wallac OY 940 Winter St., Waltham MA
Third party review
No

Clearances, product code PJI

Trailing 12 months

FDA records hold no clearances under product code PJI in the trailing twelve months.

FDA records show no clearances under product code PJI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260