Cleared Traditional

POLY-CHEM 90 ISE MODULE

K112408 · Polymedco, Inc. · Chemistry
Nov 2011
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K112408 is an FDA 510(k) clearance for the POLY-CHEM 90 ISE MODULE, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on November 4, 2011, 74 days after receiving the submission on August 22, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K112408 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2011
Decision Date November 04, 2011
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEM — Electrode, Ion Specific, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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