Cleared Traditional

MISSION OLYMPUS AU ISE CALIBRATORS

K071039 · Diamond Diagnostics, Inc. · Chemistry
Aug 2007
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K071039 is an FDA 510(k) clearance for the MISSION OLYMPUS AU ISE CALIBRATORS, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on August 8, 2007, 118 days after receiving the submission on April 12, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K071039 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2007
Decision Date August 08, 2007
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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