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510(k) K121224

GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM by Taidoc Technology Corporation — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2012
Date Received
April 20, 2012
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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