Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)— 510(k) K241800
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K241800 for Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC), Substantially Equivalent on 2024-07-26. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code MRR
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