Cleared Traditional

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS

K121433 · Hmd Biomedical, Inc. · Chemistry
Feb 2013
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K121433 is an FDA 510(k) clearance for the GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Hmd Biomedical, Inc. (Xinpu Township, Hsinchu County, TW). The FDA issued a Cleared decision on February 14, 2013, 276 days after receiving the submission on May 14, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K121433 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2012
Decision Date February 14, 2013
Days to Decision 276 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LFR — Glucose Dehydrogenase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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