510(k) DEN140010
DEN140010 is an FDA 510(k) premarket notification submitted by Wallac OY for the device "PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM". The FDA issued a decision of De Novo Granted on December 15, 2014. The device falls under product code PJI (Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System), a Class II device regulated under 21 CFR 866.5930. Wallac OY has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 15, 2014
- Date Received
- February 19, 2014
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
- Device Class
- Class II
- Regulation Number
- 866.5930
- Review Panel
- IM
- Submission Type
A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).