Cleared Traditional

OXICOM CONTROL

K053327 · Bionostics, Inc. · Chemistry
Jan 2006
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K053327 is an FDA 510(k) clearance for the OXICOM CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on January 26, 2006, 56 days after receiving the submission on December 1, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K053327 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2005
Decision Date January 26, 2006
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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