Cleared Traditional

RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS

K081478 · Bionostics, Inc. · Chemistry
Oct 2008
Decision
132d
Days
Class 1
Risk

About This 510(k) Submission

K081478 is an FDA 510(k) clearance for the RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS, 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 October 6, 2008, 132 days after receiving the submission on May 27, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K081478 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2008
Decision Date October 06, 2008
Days to Decision 132 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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