Cleared Traditional

K060206 - MISSION COMPLETE
(FDA 510(k) Clearance)

K060206 · Diamond Diagnostics, Inc. · Chemistry

Mar 2006

Decision

54d

Days

Class 1

Risk

K060206 is an FDA 510(k) clearance for the MISSION COMPLETE. This device is classified as 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 21, 2006, 54 days after receiving the submission on January 26, 2006.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K060206 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 2006
Decision Date	March 21, 2006
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF