Cleared Traditional

K093384 - MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
(FDA 510(k) Clearance)

K093384 · Diamond Diagnostics, Inc. · Chemistry

Mar 2010

Decision

131d

Days

Class 1

Risk

K093384 is an FDA 510(k) clearance for the MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3), 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 10, 2010, 131 days after receiving the submission on October 30, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K093384 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 2009
Decision Date	March 10, 2010
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF