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.

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
No devices found for this product code.

About Product Code PQW - Regulatory Context