Cleared Traditional

POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS

K110818 · Polymedco, Inc. · Chemistry
Sep 2011
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K110818 is an FDA 510(k) clearance for the POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on September 8, 2011, 168 days after receiving the submission on March 24, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K110818 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2011
Decision Date September 08, 2011
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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