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 |