K251968
- 510(k) number
- K251968
- Device name
- HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
- Applicant
- Instrumentation Laboratory (IL) Co. MA · US
- Product code
- KQJ — System, Fibrinogen Determination
- Decision date
- 2025-07-24
- Date received
- 2025-06-26
- 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: K251968.pdf
Official FDA record: K251968
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.