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

Muscular Dystrophy Newborn Screening Test

21 CFR 862.1506 / Clinical Chemistry
FDA source (opens on fda.gov)

QJE is the FDA product code for Muscular Dystrophy Newborn Screening Test, a class II device type, regulated under 21 CFR 862.1506. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QJE
Device name
Muscular Dystrophy Newborn Screening Test
FDA definition
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.
Regulation
21 CFR 862.1506
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
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QJE

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

Applicants with the most clearances

Product code QJE
Applicants holding the most 510(k) clearances under product code QJE
ApplicantClearances
Revvity Health Sciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code