QUIKREAD CRP CALIBRATOR SET— 510(k) K042625

Name: FDA 510(k) clearance K042625
Creator: U.S. Food and Drug Administration
Published: 2004-11-18

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. Device class: 1.

Clearance details

Applicant: Orion Diagnostica, OY
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
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 ↗

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