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510(k) K133537

EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM by Eps Bio Technology Corp. — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2014
Date Received
November 18, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Dehydrogenase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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  • K111728 — EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOS (September 16, 2011)
  • K112272 — EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOS (September 7, 2011)

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  • K121224 — GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (September 19, 2012)
  • K113307 — GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (July 27, 2012)