Cleared Traditional

EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT

K123802 · Medica Corp. · Chemistry
Mar 2013
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K123802 is an FDA 510(k) clearance for the EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK 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 March 1, 2013, 81 days after receiving the submission on December 10, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K123802 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2012
Decision Date March 01, 2013
Days to Decision 81 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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