K260551
- 510(k) number
- K260551
- Device name
- HemosIL Factor V Leiden (APC Resistance V)
- Applicant
- Instrumentation Laboratory (IL) Co. MA · US
- Product code
- GGW — Test, Time, Partial Thromboplastin
- Decision date
- 2026-03-20
- Date received
- 2026-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260551.pdf
Official FDA record: K260551
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.