Cleared Special

VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7

K152433 · Ortho-Clinical Diagnostics · Immunology
Sep 2015
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K152433 is an FDA 510(k) clearance for the VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7, 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 September 24, 2015, 28 days after receiving the submission on August 27, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K152433 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2015
Decision Date September 24, 2015
Days to Decision 28 days
Submission Type Special
Review Panel Immunology (IM)
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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