MRR
- Product code
- MRR
- Device name
- System, Test, Low Density, Lipoprotein
- Device class
- Class 1
- 21 CFR
- 21 CFR 862.1475
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 31 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241800 | 2024-07-26 | Siemens Healthcare Diagnostics, Inc. | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LD… |
Official FDA classification page: MRR
Classification and pathway per current FDA publications. Data from openFDA (CC0).