HemosIL Factor V Leiden (APC Resistance V)— 510(k) K260551
Substantially EquivalentInstrumentation Laboratory (IL) Co.
FDA 510(k) clearance K260551 for HemosIL Factor V Leiden (APC Resistance V), Substantially Equivalent on 2026-03-20. Applicant: Instrumentation Laboratory (IL) Co..
Clearance details
- Applicant
- Instrumentation Laboratory (IL) Co.
- Product code
- Code GGW
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.