MRR

System, Test, Low Density, Lipoprotein

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)

Last three years. Most recent: 2024-07-26.

NumberDecision dateApplicantDevice nameSummary
K2418002024-07-26Siemens Healthcare Diagnostics, Inc.Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LD…PDF

1 summaries are archived here for direct download.

Official FDA classification page: MRR
Classification and pathway per current FDA publications. Data from openFDA (CC0).