Cleared Traditional

EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT

K080874 · Medica Corp. · Chemistry
Feb 2009
Decision
326d
Days
Class 2
Risk

About This 510(k) Submission

K080874 is an FDA 510(k) clearance for the EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on February 20, 2009, 326 days after receiving the submission on March 31, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K080874 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2008
Decision Date February 20, 2009
Days to Decision 326 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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