QJE — Muscular Dystrophy Newborn Screening Test Class II
FDA product code QJE covers "Muscular Dystrophy Newborn Screening Test", a Class II medical device regulated under 21 CFR 862.1506. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QJE
- Device Class
- Class II
- Regulation Number
- 862.1506
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN180056 | perkinelmer | GSP Neonatal Creatine Kinase - MM kit | December 12, 2019 |