GSP NEONATAL TOTAL GALACTOSE KIT— 510(k) K133652
Substantially EquivalentWallac Oy, A Subsidiary of Perkinelmer, Inc.
FDA 510(k) clearance K133652 for GSP NEONATAL TOTAL GALACTOSE KIT, Substantially Equivalent on 2014-04-28. Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc..
Clearance details
- Applicant
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Product code
- Code JIA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.