QUIKREAD CRP CALIBRATOR SET— 510(k) K042625

Substantially Equivalent

Orion Diagnostica, OY

FDA 510(k) clearance K042625 for QUIKREAD CRP CALIBRATOR SET, Substantially Equivalent on 2004-11-18. Applicant: Orion Diagnostica, OY.

Clearance details

Applicant: Orion Diagnostica, OY
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2004-09-27
Decision date: 2004-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Espoo, FI

Download summary PDF View on FDA.gov ↗

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