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510(k) K131366

ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM by Roche Diagnostics Operations, Inc. — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2013
Date Received
May 13, 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

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Other clearances for product code LFR

  • K152328 — FreeStyle InsuLinx Blood Glucose Monotioring System (September 17, 2015)
  • K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM (December 17, 2014)
  • K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUC (April 28, 2014)
  • K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM (February 28, 2014)
  • 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)