510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K173829Substantially Equivalent

NeoLSD MSMS kit

Wallac Oy, A Subsidiary of Perkinelmer, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173829 is the FDA 510(k) clearance record for NeoLSD MSMS kit, a class II device, cleared for Wallac Oy, A Subsidiary of Perkinelmer on under FDA product code PQW (Alpha-D-Galactosidase A (Gla) Newborn Screening Test System). FDA's definition for product code PQW reads: "For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens". FDA records list 4 510(k) clearances for Wallac Oy, A Subsidiary of Perkinelmer, from to . As of , FDA records show no recalls naming K173829.

Clearance record

Decision date
Received
(212 days to decision)
Product code
PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Regulation
21 CFR 862.1488
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Wallac Oy, A Subsidiary of Perkinelmer 940 Winter St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQW

Trailing 12 months

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

FDA records show no clearances under product code PQW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PQW, 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