Cleared Traditional

MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL

K021930 · Bionostics, Inc. · Chemistry
Jun 2002
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K021930 is an FDA 510(k) clearance for the MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on June 25, 2002, 13 days after receiving the submission on June 12, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K021930 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2002
Decision Date June 25, 2002
Days to Decision 13 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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