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510(k) K152328

FreeStyle InsuLinx Blood Glucose Monotioring System by Abott Laboratories — Product Code LFR

K152328 is an FDA 510(k) premarket notification submitted by Abott Laboratories for the device "FreeStyle InsuLinx Blood Glucose Monotioring System". The FDA issued a decision of Substantially Equivalent on September 17, 2015. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2015
Date Received
August 18, 2015
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

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  • 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)
  • K113307 — GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (July 27, 2012)

FDA data resources