AUTODELFIA NEONATAL IRT KIT, MODEL B005-112— 510(k) K003668
Substantially EquivalentWallac OY
FDA 510(k) clearance K003668 for AUTODELFIA NEONATAL IRT KIT, MODEL B005-112, Substantially Equivalent on 2001-02-12. Applicant: Wallac OY.
Clearance details
- Applicant
- Wallac OY
- Product code
- Code CGZ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Turku, FI
Data sourced from openFDA. This site is unofficial and independent of the FDA.