Cleared Traditional

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

K103364 · Diamond Diagnostics, Inc. · Chemistry
May 2011
Decision
171d
Days
Class 1
Risk

About This 510(k) Submission

K103364 is an FDA 510(k) clearance for the MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL, 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 May 6, 2011, 171 days after receiving the submission on November 16, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K103364 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2010
Decision Date May 06, 2011
Days to Decision 171 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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