K251564
- 510(k) number
- K251564
- Device name
- microINR System
- Applicant
- Iline Microsystems, S.L. ES
- Product code
- GJS — Test, Time, Prothrombin
- Decision date
- 2025-07-21
- Date received
- 2025-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251564.pdf
Official FDA record: K251564
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.