510(k) DEN140010 ยท PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
| Applicant | Wallac OY, Waltham MA, US |
| Decision | Unknown, Dec 15, 2014 |
| Received | Feb 19, 2014 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN140010
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.