Panels › Clinical Chemistry › Product code QJE · Class 2
Muscular Dystrophy Newborn Screening Test
Regulation 862.1506
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QJE
| Company | 510(k)s | Recalls |
|---|---|---|
| Perkinelmer, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 2019 | DEN180056 | GSP Neonatal Creatine Kinase - MM kit Perkinelmer, Inc. | QJE |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.