Panels › Immunology › Product code PJI · Class 2
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Regulation 866.5930
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in PJI
| Company | 510(k)s | Recalls |
|---|---|---|
| Perkinelmer, Inc. | 1 | 0 |
| PerkinElmer Health Sciences, Inc. | 0 | 1 |
| Wallac OY | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2022 | K203035 | Eonis SCID-SMA kit Perkinelmer, Inc. | PJI |
| Dec 15, 2014 | DEN140010 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM Wallac OY | PJI |
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