K221359
- 510(k) number
- K221359
- Device name
- ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
- Applicant
- Instrumentation Laboratory CO MA · US
- Product code
- JPA — System, Multipurpose For In Vitro Coagulation Studie
- Decision date
- 2023-09-29
- Date received
- 2022-05-11
- 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: K221359.pdf
Official FDA record: K221359
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.