Cleared Traditional

NeoLSD MSMS Kit

K190266 · Perkinelmer, Inc. · Chemistry
May 2019
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K190266 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 Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on May 3, 2019, 84 days after receiving the submission on February 8, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1488.

Submission Details

510(k) Number K190266 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2019
Decision Date May 03, 2019
Days to Decision 84 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.