Cleared Traditional

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR

K093492 · Diamond Diagnostics, Inc. · Chemistry
Mar 2010
Decision
129d
Days
Class 1
Risk

About This 510(k) Submission

K093492 is an FDA 510(k) clearance for the MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR, 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 March 19, 2010, 129 days after receiving the submission on November 10, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K093492 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2009
Decision Date March 19, 2010
Days to Decision 129 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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