Cleared Traditional

ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL

K032453 · Bionostics, Inc. · Chemistry
Aug 2003
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K032453 is an FDA 510(k) clearance for the ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE 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 August 28, 2003, 17 days after receiving the submission on August 11, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K032453 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2003
Decision Date August 28, 2003
Days to Decision 17 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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