AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
FDA 510(k) clearance K072686 · decided 2008-03-17
Clearance details
- K-number
- K072686
- Device name
- AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-24
- Decision date
- 2008-03-17
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.