VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA— 510(k) K091284
Substantially EquivalentAffinity Biologicals, Inc.
FDA 510(k) clearance K091284 for VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA, Substantially Equivalent on 2009-10-28. Applicant: Affinity Biologicals, Inc..
Clearance details
- Applicant
- Affinity Biologicals, Inc.
- Product code
- Code GGN
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ancaster, Ontario, CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.