Orion Diagnostica Quikread CRP Kit and Quikread CRP Control

FDA 510(k) K031607 · Orion Diagnostica, Div. Orion Corp.

Substantially Equivalent

510(k) numberK031607

Submission

Device name
Orion Diagnostica Quikread CRP Kit and Quikread CRP Control
Applicant
Orion Diagnostica, Div. Orion Corp.
Espoo, FI
Received
May 22, 2003
Decision date
October 10, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DCK – C-Reactive Protein, Antigen, Antiserum, And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5270
Specialty
Immunology

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Questions and answers

When was Orion Diagnostica Quikread CRP Kit and Quikread CRP Control cleared by the FDA?

Orion Diagnostica Quikread CRP Kit and Quikread CRP Control (K031607) received a 510(k) decision of Substantially Equivalent on October 10, 2003, 141 days after the submission was received.

What is the product code of K031607?

The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.