K233663
- 510(k) number
- K233663
- Device name
- N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
- Applicant
- Siemens Healthcare Diagnostics Products GmbH DE
- Product code
- CFN — Method, Nephelometric, Immunoglobulins (G, A, M)
- Decision date
- 2023-12-13
- Date received
- 2023-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K233663.pdf
Official FDA record: K233663
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.