MRR · Class I · 21 CFR 862.1475

FDA Product Code MRR: System, Test, Low Density, Lipoprotein

Leading manufacturers include Siemens Healthcare Diagnostics, Inc..

31
Total
31
Cleared
139d
Avg days
1990
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 35d recently vs 142d historically

FDA 510(k) Cleared System, Test, Low Density, Lipoprotein Devices (Product Code MRR)

31 devices
1–24 of 31
Cleared Jul 26, 2024
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
K241800
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d

About Product Code MRR - Regulatory Context

510(k) Submission Activity

31 total 510(k) submissions under product code MRR since 1990, with 31 receiving FDA clearance (average review time: 139 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA Review Time

Recent submissions under MRR have taken an average of 35 days to reach a decision - down from 142 days historically, suggesting improved FDA processing for this classification.

MRR devices are reviewed by the Chemistry panel. Browse all Chemistry devices →