HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
FDA 510(k) clearance K020935 · decided 2002-04-03
Clearance details
- K-number
- K020935
- Device name
- HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
- Applicant
- Hemocue, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-22
- Decision date
- 2002-04-03
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Potomac, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (o recall (Z-2070-2025) | HemoCue AB | 2025-07-02 |
| HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for recall (Z-0873-2015) | Radiometer America Inc | 2014-12-24 |
| HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glu recall (Z-2190-2013) | HemoCue AB | 2013-09-11 |
| HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717* recall (Z-0824-2012) | Hemo Cue, Inc. | 2012-01-20 |