GSP NEONATAL IRT KIT (3306-001U)— 510(k) K102419
Substantially EquivalentWallac Oy, Subsidiary of Perkinelmer
FDA 510(k) clearance K102419 for GSP NEONATAL IRT KIT (3306-001U), Substantially Equivalent on 2010-12-16. Applicant: Wallac Oy, Subsidiary of Perkinelmer.
Clearance details
- Applicant
- Wallac Oy, Subsidiary of Perkinelmer
- Product code
- Code JNO
- 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.