510(k) DEN180056
DEN180056 is an FDA 510(k) premarket notification submitted by Perkinelmer, Inc. for the device "GSP Neonatal Creatine Kinase - MM kit". The FDA issued a decision of De Novo Granted on December 12, 2019. The device falls under product code QJE (Muscular Dystrophy Newborn Screening Test), a Class II device regulated under 21 CFR 862.1506. Perkinelmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 12, 2019
- Date Received
- October 11, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Muscular Dystrophy Newborn Screening Test
- Device Class
- Class II
- Regulation Number
- 862.1506
- Review Panel
- CH
- Submission Type
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.