AFINION HBALC— 510(k) K050574
Substantially EquivalentAxis-Shield Poc AS
FDA 510(k) clearance K050574 for AFINION HBALC, Substantially Equivalent on 2005-07-22. Applicant: Axis-Shield Poc AS.
Clearance details
- Applicant
- Axis-Shield Poc AS
- Product code
- Code LCP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.