K230852
- 510(k) number
- K230852
- Device name
- HemosIL Chromogenic Factor IX
- Applicant
- Instrumentation Laboratory Company MA · US
- Product code
- GGP — Test, Qualitative And Quantitative Factor Deficiency
- Decision date
- 2023-12-13
- Date received
- 2023-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230852.pdf
Official FDA record: K230852
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.