K253957
- 510(k) number
- K253957
- Device name
- HemosIL Silica Clotting Time
- Applicant
- Instrumentation Laboratory (IL) Co. MA · US
- Product code
- GFO — Activated Partial Thromboplastin
- Decision date
- 2026-01-09
- Date received
- 2025-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253957.pdf
Official FDA record: K253957
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.