PQW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1488
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- FDA definition
- For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NeoLSD MSMS Kit (K190266) | Perkinelmer, Inc. | 2019-05-03 |
| NeoLSD MSMS kit (K173829) | Wallac Oy, A Subsidiary of Perkinelmer | 2018-07-18 |
| SEEKER System (DEN150035) | Baebies, Inc. | 2017-02-03 |
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Every clearance here is in the API, with alerts when new ones post.