K233790
- 510(k) number
- K233790
- Device name
- ACL TOP 970 CL
- Applicant
- Instrumentation Laboratory MA · US
- Product code
- JPA — System, Multipurpose For In Vitro Coagulation Studie
- Decision date
- 2023-12-29
- Date received
- 2023-11-28
- 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: K233790.pdf
Official FDA record: K233790
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.