510(k) K173829
K173829 is an FDA 510(k) premarket notification submitted by Wallac Oy, A Subsidiary of Perkinelmer for the device "NeoLSD MSMS kit". The FDA issued a decision of Substantially Equivalent on July 18, 2018. The device falls under product code PQW (Alpha-D-Galactosidase A (Gla) Newborn Screening Test System), a Class II device regulated under 21 CFR 862.1488. Wallac Oy, A Subsidiary of Perkinelmer has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2018
- Date Received
- December 18, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
- Device Class
- Class II
- Regulation Number
- 862.1488
- Review Panel
- CH
- Submission Type
For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.