Cleared Traditional

VITROS Chemistry Products GLU Slides

K163433 · Ortho-Clinical Diagnostics · Chemistry
Sep 2017
Decision
285d
Days
Class 2
Risk

About This 510(k) Submission

K163433 is an FDA 510(k) clearance for the VITROS Chemistry Products GLU Slides, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on September 18, 2017, 285 days after receiving the submission on December 7, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K163433 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2016
Decision Date September 18, 2017
Days to Decision 285 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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