DELFIA NEONATAL THYROXINE KIT— 510(k) K943416
Substantially EquivalentWallac OY
FDA 510(k) clearance K943416 for DELFIA NEONATAL THYROXINE KIT, Substantially Equivalent on 1995-03-10. Applicant: Wallac OY. Device class: 2.
Clearance details
- Applicant
- Wallac OY
- Product code
- Code CDX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Finland, FI
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Data sourced from openFDA. This site is unofficial and independent of the FDA.