Cleared Traditional

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C

K124009 · Diamond Diagnostics, Inc. · Chemistry
Apr 2013
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K124009 is an FDA 510(k) clearance for the MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on April 17, 2013, 111 days after receiving the submission on December 27, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K124009 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2012
Decision Date April 17, 2013
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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