PQW · Class II · 21 CFR 862.1488

FDA Product Code PQW: Alpha-d-galactosidase A (gla) Newborn Screening Test System

For Quantitative Measurement Of The Activity Of Alpha-d-galactosidase A (gla) From Newborn Dried Blood Spot Specimens.

Leading manufacturers include Wallac Oy, A Subsidiary of Perkinelmer and Perkinelmer, Inc..

3
Total
2
Cleared
281d
Avg days
2017
Since

FDA 510(k) Cleared Alpha-d-galactosidase A (gla) Newborn Screening Test System Devices (Product Code PQW)

3 devices
1–3 of 3
Cleared May 03, 2019
NeoLSD MSMS Kit
K190266
Perkinelmer, Inc.
Chemistry · 84d
Cleared Jul 18, 2018
NeoLSD MSMS kit
K173829
Wallac Oy, A Subsidiary of Perkinelmer
Chemistry · 212d

About Product Code PQW - Regulatory Context