Cleared Special

EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200

K091991 · Medica Corp. · Chemistry
Sep 2009
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K091991 is an FDA 510(k) clearance for the EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on September 4, 2009, 64 days after receiving the submission on July 2, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K091991 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2009
Decision Date September 04, 2009
Days to Decision 64 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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