Cleared Traditional

EASYRA UREA NITROGEN AND CREATININE REAGENTS

K110675 · Medica Corp. · Chemistry
Apr 2011
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K110675 is an FDA 510(k) clearance for the EASYRA UREA NITROGEN AND CREATININE REAGENTS, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on April 21, 2011, 42 days after receiving the submission on March 10, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K110675 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2011
Decision Date April 21, 2011
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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