Cleared Traditional

VITROS Chemistry Products hsCRP Reagent

K160712 · Ortho-Clinical Diagnostics · Chemistry
Jul 2017
Decision
486d
Days
Class 2
Risk

About This 510(k) Submission

K160712 is an FDA 510(k) clearance for the VITROS Chemistry Products hsCRP Reagent, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on July 14, 2017, 486 days after receiving the submission on March 15, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K160712 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2016
Decision Date July 14, 2017
Days to Decision 486 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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