Cleared Traditional

COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3

K012431 · Bionostics, Inc. · Chemistry
Aug 2001
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K012431 is an FDA 510(k) clearance for the COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bionostics, Inc. (Acton, US). The FDA issued a Cleared decision on August 28, 2001, 28 days after receiving the submission on July 31, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K012431 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2001
Decision Date August 28, 2001
Days to Decision 28 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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