510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PQWClass II

Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

21 CFR 862.1488 / Clinical Chemistry
FDA source (opens on fda.gov)

PQW is the FDA product code for Alpha-D-Galactosidase A (Gla) Newborn Screening Test System, a class II device type, regulated under 21 CFR 862.1488. FDA's definition for this code reads: "For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PQW
Device name
Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
FDA definition
For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.
Regulation
21 CFR 862.1488
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code PQW

By decision year
3 clearances under product code PQW with a decision year between 2017 and 2019, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PQW by decision year
YearClearances
20171
20181
20191

Applicants with the most clearances

Product code PQW
Applicants holding the most 510(k) clearances under product code PQW
ApplicantClearances
Baebies Inc.1
Revvity Health Sciences, Inc.1
Wallac Oy, A Subsidiary of Perkinelmer, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code