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510(k) K212248

GlucoLeader Enhance 2 Blood Glucose Monitoring System by Hmd Biomedical, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2022
Date Received
July 19, 2021
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

Other clearances by Hmd Biomedical, Inc.

  • K182428 — GlucoLeader Enhance Blood Glucose Monitoring System (May 8, 2019)
  • K140150 — Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose M (May 14, 2015)
  • K131173 — FIA Blood Glucose Monitoring System (G2) (September 18, 2014)
  • 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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