Cleared Traditional

MISSION TRINITY B

K062674 · Diamond Diagnostics, Inc. · Chemistry
Dec 2006
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K062674 is an FDA 510(k) clearance for the MISSION TRINITY B, 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 December 1, 2006, 84 days after receiving the submission on September 8, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K062674 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2006
Decision Date December 01, 2006
Days to Decision 84 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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