K242685
- 510(k) number
- K242685
- Device name
- Atellica® CH Creatinine_3 (Crea3)
- Applicant
- Siemens Healthcare Diagnostics, Inc. NY · US
- Product code
- CGX — Alkaline Picrate, Colorimetry, Creatinine
- Decision date
- 2024-12-04
- Date received
- 2024-09-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242685.pdf
Official FDA record: K242685
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.