510(k) K052825— VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
Substantially EquivalentAffinity Biologicals, Inc.
Clearance details
- Applicant
- Affinity Biologicals, Inc.
- Product code
- Code GGP
- 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.