HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
FDA 510(k) clearance K041234 · decided 2004-06-10
Clearance details
- K-number
- K041234
- Device name
- HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
- Applicant
- Hemocue, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-10
- Decision date
- 2004-06-10
- Days to decision
- 31 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 AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin dete recall (Z-1849-2011) | Hemo Cue, Inc. | 2011-03-30 |