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510(k) K140141

LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM by Ceragem Medisys, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2014
Date Received
January 22, 2014
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 Ceragem Medisys, Inc.

  • K141829 — GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM (September 24, 2014)
  • K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM (February 28, 2014)
  • K102751 — LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM (February 11, 2013)

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