B-FACT, BORDERLINE FACTOR ASSAY CONTROL— 510(k) K945854
Substantially EquivalentGeorge King Bio-Medical, Inc.
FDA 510(k) clearance K945854 for B-FACT, BORDERLINE FACTOR ASSAY CONTROL, Substantially Equivalent on 1995-10-24. Applicant: George King Bio-Medical, Inc..
Clearance details
- Applicant
- George King Bio-Medical, Inc.
- Product code
- Code GGN
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.