Cleared Traditional

OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION

K091914 · Bionostics, Inc. · Chemistry
Nov 2009
Decision
129d
Days
Class 1
Risk

About This 510(k) Submission

K091914 is an FDA 510(k) clearance for the OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION, 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 November 6, 2009, 129 days after receiving the submission on June 30, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K091914 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2009
Decision Date November 06, 2009
Days to Decision 129 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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