FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
K Number: DEN140010
·
Decision Dec 15, 2014
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
22
Review Days
299
Basic Information
- Device Name
- PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
- K Number
- DEN140010
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.5930
- Medical Specialty
- Immunology
- Decision
- Unknown
- Applicant
- WALLAC OY
- Date Received
- February 19, 2014
- Decision Date
- December 15, 2014
- Product Code
- PJI
- Advisory Committee
- Immunology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| PJI | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System | FDA class 2 | Immunology |
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