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510(k) K961311

HEMOCUE B-GLUCOSE SYSTEM by Hemocue, Inc. — Product Code LFR

K961311 is an FDA 510(k) premarket notification submitted by Hemocue, Inc. for the device "HEMOCUE B-GLUCOSE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 23, 1996. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Hemocue, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1996
Date Received
April 4, 1996
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 Hemocue, Inc.

  • K201217 — HemoCue Hb 301 System (August 4, 2020)
  • K181751 — HemoCue Hb 801 System (February 1, 2019)
  • K071652 — HEMOCUE WBC SYSTEM (October 25, 2007)
  • K060765 — HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES (September 6, 2006)
  • K061047 — HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 (June 8, 2006)
  • K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (February 17, 2006)
  • K041234 — HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM (June 10, 2004)
  • K041230 — CLINICAL LABORATORY ANALYZING SYSTEM (May 20, 2004)
  • K032203 — HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 (August 25, 2003)
  • K020935 — HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (April 3, 2002)

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