CLINICAL LABORATORY ANALYZING SYSTEM
FDA 510(k) clearance K041230 · decided 2004-05-20
Clearance details
- K-number
- K041230
- Device name
- CLINICAL LABORATORY ANALYZING SYSTEM
- Applicant
- Hemocue, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-10
- Decision date
- 2004-05-20
- Days to decision
- 10 days
- Clearance type
- Special
- Product code
- LFR
- 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 |
|---|---|---|
| HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determinat recall (Z-1848-2011) | Hemo Cue, Inc. | 2011-03-30 |