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510(k) K132072

TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM by Nipro Diagnostics, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2013
Date Received
July 3, 2013
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

Other clearances by Nipro Diagnostics, Inc.

  • K150052 — TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Profes (March 26, 2015)
  • K140100 — TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL M (August 1, 2014)
  • K120989 — TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONIT (April 24, 2013)

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