Cleared Traditional

POLY-CHEM 90 TOTAL BILIRUBIN

K111143 · Polymedco, Inc. · Chemistry
Sep 2011
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K111143 is an FDA 510(k) clearance for the POLY-CHEM 90 TOTAL BILIRUBIN, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on September 1, 2011, 132 days after receiving the submission on April 22, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K111143 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2011
Decision Date September 01, 2011
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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