Panels › Clinical Chemistry › Product code PQW · Class 2
Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Regulation 862.1488
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PQW
| Company | 510(k)s | Recalls |
|---|---|---|
| Baebies, Inc. | 1 | 0 |
| Perkinelmer, Inc. | 1 | 0 |
| Wallac Oy, A Subsidiary of Perkinelmer | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 3, 2019 | K190266 | NeoLSD MSMS Kit Perkinelmer, Inc. | PQW |
| Jul 18, 2018 | K173829 | NeoLSD MSMS kit Wallac Oy, A Subsidiary of Perkinelmer | PQW |
| Feb 3, 2017 | DEN150035 | SEEKER System Baebies, Inc. | PQW |
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