510(k) K173829
- Device
- NeoLSD MSMS Kit
- Applicant
- Wallac Oy, A Subsidiary Of PerkinElmer
- 510(k) number
- K173829
- Product code
- PQW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-18
- Date received
- 2017-12-18
- Regulation
- 862.1488
- Classification name
- Alpha-d-galactosidase A (gla) Newborn Screening Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kay A Taylor
- Address
- 940 Winter St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 3042250641
- 8043909
- 3011240982
Source Documents#
Other 510(k) Records For Product Code PQW #
Legacy Summary#
summary
FDA Review#
Decision Summary