Cleared Traditional

EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL

K120497 · Medica Corp. · Chemistry
May 2012
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K120497 is an FDA 510(k) clearance for the EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on May 14, 2012, 83 days after receiving the submission on February 21, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K120497 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2012
Decision Date May 14, 2012
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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