Device Atlas

NeoLSD MSMS kit

Q: When was NeoLSD MSMS kit cleared by the FDA?

NeoLSD MSMS kit (K173829) received a 510(k) decision of Substantially Equivalent on July 18, 2018, 212 days after the submission was received.

Q: What is the product code of K173829?

The FDA product code is PQW – Alpha-D-Galactosidase A (Gla) Newborn Screening Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1488.

FDA 510(k) K173829 · Wallac Oy, A Subsidiary of Perkinelmer

Substantially Equivalent

510(k) numberK173829

Submission

Device name: NeoLSD MSMS kit
Applicant: Wallac Oy, A Subsidiary of Perkinelmer
Waltham, MA, US
Received: December 18, 2017
Decision date: July 18, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PQW – Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1488
Specialty: Clinical Chemistry

For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.

Other 510(k)s with product code PQW

510(k)	Device	Applicant	Decision
K190266	NeoLSD MSMS KitPQW · Traditional	Perkinelmer, Inc.	05/03/2019SE

More from Perkinelmer, Inc.

510(k)	Device	Decision
K133652	GSP Neonatal Total Galactose KitJIA · Traditional	04/28/2014SE
K110274	Autodelfia Neonatal Irt KitJNO · Traditional	06/10/2011SE
K103484	GSP Neonatal Thyroxine (T4)KLI · Traditional	04/22/2011SE

Questions and answers

When was NeoLSD MSMS kit cleared by the FDA?

NeoLSD MSMS kit (K173829) received a 510(k) decision of Substantially Equivalent on July 18, 2018, 212 days after the submission was received.

What is the product code of K173829?

The FDA product code is PQW – Alpha-D-Galactosidase A (Gla) Newborn Screening Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1488.