Cleared Traditional

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

K142993 · Orion Diagnostica, OY · Immunology

Mar 2016

Decision

511d

Days

Class 2

Risk

About This 510(k) Submission

K142993 is an FDA 510(k) clearance for the QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Orion Diagnostica, OY (Oulu, FI). The FDA issued a Cleared decision on March 10, 2016, 511 days after receiving the submission on October 16, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K142993 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 16, 2014
Decision Date	March 10, 2016
Days to Decision	511 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement