AFINION HBALC
FDA 510(k) clearance K050574 · decided 2005-07-22
Clearance details
- K-number
- K050574
- Device name
- AFINION HBALC
- Applicant
- Axis-Shield Poc AS
- Decision
- Substantially Equivalent
- Date received
- 2005-03-07
- Decision date
- 2005-07-22
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.