Cleared Traditional

EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT

K080810 · Medica Corp. · Chemistry
Dec 2008
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K080810 is an FDA 510(k) clearance for the EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on December 10, 2008, 264 days after receiving the submission on March 21, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K080810 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2008
Decision Date December 10, 2008
Days to Decision 264 days
Submission Type Traditional
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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