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510(k) K131727

CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM by Ceragem Medisys, Inc. — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2014
Date Received
June 12, 2013
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

Other clearances by Ceragem Medisys, Inc.

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  • K140141 — LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM (July 3, 2014)
  • K102751 — LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM (February 11, 2013)

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  • K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (October 11, 2013)
  • K122688 — NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (April 4, 2013)
  • K121433 — GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) (February 14, 2013)
  • K122435 — NOVA ONE BLOOD GLUCOSE MONITOR (December 20, 2012)
  • K113314 — PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (November 9, 2012)
  • K121224 — GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (September 19, 2012)
  • K113307 — GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (July 27, 2012)