QJE · Class II · 21 CFR 862.1506

FDA Product Code QJE: Muscular Dystrophy Newborn Screening Test

A Muscular Dystrophy Newborn Screening Test Is Intended To Measure Creatine Kinase Levels Obtained From Dried Blood Spot Specimens On Filter Paper From Newborns As An Aid In Screening Newborns For Muscular Dystrophy.

1
Total
0
Cleared
427d
Avg days
2019
Since

FDA 510(k) Cleared Muscular Dystrophy Newborn Screening Test Devices (Product Code QJE)

1 devices
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About Product Code QJE - Regulatory Context