ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL— 510(k) K031607

Name: FDA 510(k) clearance K031607
Creator: U.S. Food and Drug Administration
Published: 2003-10-10

Substantially Equivalent

Orion Diagnostica, Div. Orion Corp.

FDA 510(k) clearance K031607 for ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL, Substantially Equivalent on 2003-10-10. Applicant: Orion Diagnostica, Div. Orion Corp.. Device class: 2.

Clearance details

Applicant: Orion Diagnostica, Div. Orion Corp.
Product code: Code DCK
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2003-05-22
Decision date: 2003-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Espoo, FI

Download summary PDF View on FDA.gov ↗

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