Home / 510(k) Clearances / K111728

510(k) K111728

EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM by Eps Bio Technology Corp. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2011
Date Received
June 20, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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

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