Cleared Special

K140150 - Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 (FDA 510(k) Clearance)

K140150 · Hmd Biomedical, Inc. · Chemistry device

May 2015

Decision

477d

Days

Class 2

Risk

K140150 is an FDA 510(k) clearance for the Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).

Submitted by Hmd Biomedical, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on May 14, 2015, 477 days after receiving the submission on January 22, 2014.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K140150 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 22, 2014
Decision Date	May 14, 2015
Days to Decision	477 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF