K243374
- 510(k) number
- K243374
- Device name
- HemosIL CL HIT-IgG(PF4-H)
- Applicant
- Instrumentation Laboratory (IL) Co. MA · US
- Product code
- LCO — Platelet Factor 4 Radioimmunoassay
- Decision date
- 2025-01-28
- Date received
- 2024-10-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243374.pdf
Official FDA record: K243374
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.