Cleared Traditional

NeoLSD MSMS kit

K173829 · Wallac Oy, A Subsidiary of Perkinelmer · Chemistry
Jul 2018
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K173829 is an FDA 510(k) clearance for the NeoLSD MSMS kit, a Alpha-d-galactosidase A (gla) Newborn Screening Test System (Class II — Special Controls, product code PQW), submitted by Wallac Oy, A Subsidiary of Perkinelmer (Waltham, US). The FDA issued a Cleared decision on July 18, 2018, 212 days after receiving the submission on December 18, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1488.

Submission Details

510(k) Number K173829 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2017
Decision Date July 18, 2018
Days to Decision 212 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code PQW — Alpha-d-galactosidase A (gla) Newborn Screening Test System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1488
Definition For Quantitative Measurement Of The Activity Of Alpha-d-galactosidase A (gla) From Newborn Dried Blood Spot Specimens.