Cleared Traditional

EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT

K101088 · Medica Corp. · Chemistry
Apr 2011
Decision
350d
Days
Class 2
Risk

About This 510(k) Submission

K101088 is an FDA 510(k) clearance for the EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS 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 April 4, 2011, 350 days after receiving the submission on April 19, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K101088 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2010
Decision Date April 04, 2011
Days to Decision 350 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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