Hemocue, Inc.
Medical device manufacturer in Angelholm, Swed.
15510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | 08/04/2020SE |
| K181751 | HemoCue Hb 801 SystemGKR · Traditional | 02/01/2019SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | 10/25/2007SE |
| K060765 | Hemocue Glucose 201 RT Analyzer MDL 120731, Hemocue Glucose 201 RT Microcurettes MDL…LFR · Traditional | 09/06/2006SE |
| K061047 | Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801GKR · Traditional | 06/08/2006SE |
| K053253 | Hemocue Albumin 201 Analyzing SystemKQO · Traditional | 02/17/2006SE |
| K041234 | Hemocue Hemoglobin 201DM Analyzing SystemGKR · Special | 06/10/2004SE |
| K041230 | Clinical Laboratory Analyzing SystemLFR · Special | 05/20/2004SE |
| K032203 | Hemocue Hemoglobin 201 + System Article 121704GKR · Special | 08/25/2003SE |
| K020935 | Hemocue Glucose 201 System, Article Number 120706CGA · Special | 04/03/2002SE |
| K962415 | Hemocue B-Glcose SystemLFR · Traditional | 10/15/1996SE |
| K961312 | Hemocue B-Hemoglobin SystemGKR · Traditional | 09/24/1996SE |
| K961311 | Hemocue B-Glucose SystemLFR · Traditional | 08/23/1996SE |
| K943432 | Hemocue B-Glucose SystemCGA · Traditional | 01/17/1995SE |
| K911141 | Hemocue(R) B-Glucose Microcuvette/PhotometerCGA · Traditional | 05/08/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2070-2025 Class II | The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201…Glucose microcuvettes experienced transit time outside of limits, so stability through the whole… | 05/12/2025Open, Classified |
| Z-0101-2014 Class II | HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB…HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes… | 07/25/2013Terminated |
| Z-0086-2014 Class II | HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The…HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin… | 07/16/2013Terminated |
| Z-2190-2013 Class II | HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue…During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches. | 07/15/2013Terminated |
| Z-0619-2013 Class III | Analyzing system consists of a small and portable analyzer and plastic microcuvettes.…Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st… | 11/07/2012Terminated |