MRR · Class I · 21 CFR 862.1475

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

Leading manufacturers include Abbott Laboratories, Roche Diagnostic Systems, Inc. and Roche Diagnostics Corp..

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
Cleared Jul 19, 2023
AXINON® LDL-p Test System
K210801
Numares AG
Chemistry · 854d
Cleared May 09, 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
K020724
Dade Behring, Inc.
Chemistry · 64d
Cleared Jan 28, 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
K014103
Beckman Coulter, Inc.
Chemistry · 46d
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Oct 01, 1998
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848
Roche Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Aug 03, 1998
DIRECT LDL
K981303
Abbott Laboratories
Chemistry · 115d

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 510(k) Review Time - MRR Product Code

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 →