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510(k) K113314

PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM by Hmd Biomedical, Inc. — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2012
Date Received
November 9, 2011
Clearance Type
Traditional
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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  • K023279 — GLUCOLEADER VALUE (August 4, 2003)

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  • K122435 — NOVA ONE BLOOD GLUCOSE MONITOR (December 20, 2012)
  • K121224 — GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (September 19, 2012)
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