Home / 510(k) Clearances / K140150

510(k) 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 by Hmd Biomedical, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2015
Date Received
January 22, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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  • K121433 — GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) (February 14, 2013)
  • K113314 — PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (November 9, 2012)
  • K120064 — TEST, BLOOD GLUCOSE SYSTEM (September 5, 2012)
  • K113307 — GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (July 27, 2012)
  • K072369 — EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM (March 21, 2008)
  • K032985 — GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM (October 21, 2003)
  • K023279 — GLUCOLEADER VALUE (August 4, 2003)

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