Cleared Traditional

POLY-CHEM CREATININE

K061944 · Polymedco, Inc. · Chemistry
Nov 2006
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K061944 is an FDA 510(k) clearance for the POLY-CHEM CREATININE, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on November 3, 2006, 116 days after receiving the submission on July 10, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K061944 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2006
Decision Date November 03, 2006
Days to Decision 116 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JFY — Enzymatic Method, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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