Cleared Traditional

WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2

K941876 · More Diagnostics · Chemistry
Jul 1994
Decision
101d
Days
Class 1
Risk

About This 510(k) Submission

K941876 is an FDA 510(k) clearance for the WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on July 28, 1994, 101 days after receiving the submission on April 18, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K941876 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1994
Decision Date July 28, 1994
Days to Decision 101 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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