ORION DIAGNOSTICA UNIQ PINP RIA— 510(k) K043125

Name: FDA 510(k) clearance K043125
Creator: U.S. Food and Drug Administration
Published: 2005-05-04

Substantially Equivalent

Orion Diagnostica, OY

FDA 510(k) clearance K043125 for ORION DIAGNOSTICA UNIQ PINP RIA, Substantially Equivalent on 2005-05-04. Applicant: Orion Diagnostica, OY. Device class: 2.

Clearance details

Applicant: Orion Diagnostica, OY
Product code: Code CIN
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2004-11-12
Decision date: 2005-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Espoo, FI

Download summary PDF View on FDA.gov ↗

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