HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
FDA 510(k) clearance K053253 · decided 2006-02-17
Clearance details
- K-number
- K053253
- Device name
- HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
- Applicant
- Hemocue AB
- Decision
- Substantially Equivalent
- Date received
- 2005-11-21
- Decision date
- 2006-02-17
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KQO
- Device class
- 1
- Regulation number
- 862.2900
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The qua recall (Z-0086-2014) | HemoCue AB | 2013-10-25 |
| Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The recall (Z-0619-2013) | HemoCue AB | 2012-12-28 |