Cleared Traditional

MISSION CONTROLS

K033063 · Diamond Diagnostics, Inc. · Chemistry
Dec 2003
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K033063 is an FDA 510(k) clearance for the MISSION CONTROLS, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on December 12, 2003, 74 days after receiving the submission on September 29, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K033063 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2003
Decision Date December 12, 2003
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJS — Controls For Blood-gases, (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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