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510(k) K150052

TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System by Nipro Diagnostics, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2015
Date Received
January 12, 2015
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.

  • K140100 — TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL M (August 1, 2014)
  • K132072 — TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MO (August 15, 2013)
  • K120989 — TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONIT (April 24, 2013)

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