DELFIA NEONATAL THYROXINE KIT— 510(k) K943416

Substantially Equivalent

Wallac OY

FDA 510(k) clearance K943416 for DELFIA NEONATAL THYROXINE KIT, Substantially Equivalent on 1995-03-10. Applicant: Wallac OY.

Clearance details

Applicant: Wallac OY
Product code: Code CDX
Advisory panel: Clinical Chemistry
Date received: 1994-07-15
Decision date: 1995-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Finland, FI

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.