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HemoCue AB

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
15
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2070-2025Class IIThe HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) AnalMay 12, 2025
Z-0101-2014Class IIHemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, SweJuly 25, 2013
Z-0086-2014Class IIHemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitatJuly 16, 2013
Z-2190-2013Class IIHemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue GlucoseJuly 15, 2013
Z-0619-2013Class IIIAnalyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvetNovember 7, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K201217HemoCue Hb 301 SystemAugust 4, 2020
K181751HemoCue Hb 801 SystemFebruary 1, 2019
K071652HEMOCUE WBC SYSTEMOctober 25, 2007
K060765HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712September 6, 2006
K061047HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801June 8, 2006
K053253HEMOCUE ALBUMIN 201 ANALYZING SYSTEMFebruary 17, 2006
K041234HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEMJune 10, 2004
K041230CLINICAL LABORATORY ANALYZING SYSTEMMay 20, 2004
K032203HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704August 25, 2003
K020935HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706April 3, 2002
K962415HEMOCUE B-GLCOSE SYSTEMOctober 15, 1996
K961312HEMOCUE B-HEMOGLOBIN SYSTEMSeptember 24, 1996
K961311HEMOCUE B-GLUCOSE SYSTEMAugust 23, 1996
K943432HEMOCUE B-GLUCOSE SYSTEMJanuary 17, 1995
K911141HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETERMay 8, 1991