Cleared Traditional

CLINITEK ADVANTUS, MODEL 1420

K063276 · Bayer Healthcare, LLC · Chemistry
Dec 2006
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K063276 is an FDA 510(k) clearance for the CLINITEK ADVANTUS, MODEL 1420, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Bayer Healthcare, LLC (Norwood, US). The FDA issued a Cleared decision on December 28, 2006, 59 days after receiving the submission on October 30, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K063276 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2006
Decision Date December 28, 2006
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340

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