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510(k) K121190

CONTOUR NEXT BLOOD GLUCOSE METER by Bayer Healthcare, LLC — Product Code LFR

K121190 is an FDA 510(k) premarket notification submitted by Bayer Healthcare, LLC for the device "CONTOUR NEXT BLOOD GLUCOSE METER". The FDA issued a decision of Substantially Equivalent on July 26, 2012. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Bayer Healthcare, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2012
Date Received
April 19, 2012
Clearance Type
Special
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 Bayer Healthcare, LLC

  • K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (March 7, 2018)
  • K152852 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (December 22, 2015)
  • K150942 — Contour Next USB Blood Glucose Monitoring System (November 25, 2015)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER (June 23, 2014)
  • K122370 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (September 26, 2013)
  • K121087 — CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (June 28, 2012)
  • K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CON (March 28, 2012)
  • K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (March 28, 2012)
  • K111268 — CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM (March 6, 2012)

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)
  • 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)

FDA data resources