K233581
- 510(k) number
- K233581
- Device name
- VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
- Applicant
- Ortho Clinical Diagnostics GB
- Product code
- DHA — System, Test, Human Chorionic Gonadotropin
- Decision date
- 2024-05-08
- Date received
- 2023-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K233581.pdf
Official FDA record: K233581
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.