K232018
- 510(k) number
- K232018
- Device name
- Citrated: K, KH, RTH, FFH
- Applicant
- Haemonetics Corporation MA · US
- Product code
- JPA — System, Multipurpose For In Vitro Coagulation Studie
- Decision date
- 2024-03-29
- Date received
- 2023-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 3.6 MB · U.S. public domain
Also available from FDA: K232018.pdf
Official FDA record: K232018
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.