FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
GSP Neonatal Creatine Kinase - MM kit
K Number: DEN180056
·
Decision Dec 12, 2019
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
5
Review Days
427
Basic Information
- Device Name
- GSP Neonatal Creatine Kinase - MM kit
- K Number
- DEN180056
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 862.1506
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- PerkinElmer Inc.
- Date Received
- October 11, 2018
- Decision Date
- December 12, 2019
- Product Code
- QJE
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QJE | Muscular Dystrophy Newborn Screening Test | FDA class 2 | Clinical Chemistry |