HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
FDA 510(k) clearance K032203 · decided 2003-08-25
Clearance details
- K-number
- K032203
- Device name
- HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
- Applicant
- Hemocue, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-18
- Decision date
- 2003-08-25
- Days to decision
- 38 days
- Clearance type
- Special
- Product code
- GKR
- Device class
- 2
- Regulation number
- 864.5620
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Potomac, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angel recall (Z-0101-2014) | HemoCue AB | 2013-10-29 |