K241800
- 510(k) number
- K241800
- Device name
- Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
- Applicant
- Siemens Healthcare Diagnostics, Inc. DE · US
- Product code
- MRR — System, Test, Low Density, Lipoprotein
- Decision date
- 2024-07-26
- Date received
- 2024-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241800.pdf
Official FDA record: K241800
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.