Cleared Traditional

EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

K101089 · Medica Corp. · Chemistry
Jul 2011
Decision
450d
Days
Class 2
Risk

About This 510(k) Submission

K101089 is an FDA 510(k) clearance for the EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR, a Albumin, Antigen, Antiserum, Control (Class II — Special Controls, product code DCF), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on July 13, 2011, 450 days after receiving the submission on April 19, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K101089 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2010
Decision Date July 13, 2011
Days to Decision 450 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DCF — Albumin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5040

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