DEN180056 is an FDA 510(k) submission for the GSP Neonatal Creatine Kinase - MM kit. This device is classified as a Muscular Dystrophy Newborn Screening Test (Class II - Special Controls, product code QJE).
Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Not Cleared (DENG) decision on December 12, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1506. 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..
| 510(k) Number | DEN180056 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 11, 2018 |
| Decision Date | December 12, 2019 |
| Days to Decision | 427 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Product Code | QJE - Muscular Dystrophy Newborn Screening Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1506 |
| 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. |