The following data is part of a De Novo classification by Wallac Oy with the FDA for Perkinelmer Enlite Neonatal Trec Test System.
DeNovo ID | DEN140010 |
Device Name: | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM |
Classification | Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System |
Applicant | WALLAC OY 940 Winter Street Waltham, MA 02451 |
Contact | Kay A Taylor |
Product Code | PJI |
CFR Regulation Number | 866.5930 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Pathology |
Classification Advisory | Immunology |
Type | Direct |
Date Received | 2014-02-19 |
Decision Date | 2014-12-15 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06438147331826 | DEN140010 | 000 |
06438147331819 | DEN140010 | 000 |
06438147331802 | DEN140010 | 000 |