510(k) DEN180056
- Device
- GSP Neonatal Creatine Kinase - MM kit
- Applicant
- Perkinelmer, Inc.
- 510(k) number
- DEN180056
- Product code
- QJE
- Decision
- Unknown (DENG)
- Decision date
- 2019-12-12
- Date received
- 2018-10-11
- Regulation
- 862.1506
- Classification name
- Muscular Dystrophy Newborn Screening Test
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Brian Ciccariello
- Address
- 940 Winter St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 8043909
Source Documents#
510(k) summary PDF not indicated by FDA