Cleared Traditional

VITROS Chemistry Products Cl- Slides

K162020 · Ortho-Clinical Diagnostics · Chemistry
Dec 2016
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K162020 is an FDA 510(k) clearance for the VITROS Chemistry Products Cl- Slides, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on December 16, 2016, 148 days after receiving the submission on July 21, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K162020 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2016
Decision Date December 16, 2016
Days to Decision 148 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGZ — Electrode, Ion-specific, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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