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510(k) K110435

EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM by U. S. Diagnostics, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2011
Date Received
February 15, 2011
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

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  • K870596 — PROTHROMBIN TIME TEST (April 20, 1987)
  • K871283 — CYANMETHEMOGLOBIN STANDARD (April 15, 1987)
  • K870738 — U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL (April 13, 1987)
  • K870737 — U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL (April 13, 1987)

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