Cleared Special

PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS

K051213 · Abbott Laboratories, Inc. · Chemistry
May 2005
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K051213 is an FDA 510(k) clearance for the PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Abbott Laboratories, Inc. (Alameda, US). The FDA issued a Cleared decision on May 27, 2005, 15 days after receiving the submission on May 12, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K051213 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2005
Decision Date May 27, 2005
Days to Decision 15 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBW — System, Test, Blood Glucose, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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