MRR · Class I · 21 CFR 862.1475

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

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

31
Total
31
Cleared
139d
Avg days
1990
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

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 Jul 17, 2009
EASYRA DLDL REAGENT, CALIBRATOR
K090734
Medica Corp.
Chemistry · 120d
Cleared Aug 08, 2005
DIRECT LDL CHOLESTEROL, MODEL L530-60H
K051121
Teco Diagnostics
Chemistry · 98d
Cleared Nov 23, 2004
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
K041927
Diagnostic Chemicals , Ltd.
Chemistry · 127d
Cleared Aug 25, 2004
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
K041720
Ortho-Clinical Diagnostics, Inc.
Chemistry · 62d
Cleared Sep 17, 2002
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
K022772
Hemagen Diagnostics, Inc.
Chemistry · 27d
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 Jul 03, 2000
EZ LDL CHOLESTEROL TEST SYSTEM
K993741
Sigma Diagnostics, Inc.
Chemistry · 242d
Cleared Oct 01, 1998
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848
Roche Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Sep 22, 1998
WAKO DIRECT LDL-C
K982271
Wako Chemicals USA, Inc.
Chemistry · 85d
Cleared Sep 11, 1998
RANDOX DIRECT LDL CHOLESTEROL
K982529
Randox Laboratories, Ltd.
Chemistry · 53d
Cleared Aug 03, 1998
DIRECT LDL
K981303
Abbott Laboratories
Chemistry · 115d
Cleared Jul 22, 1998
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
K981978
Pointe Scientific, Inc.,
Chemistry · 47d
Cleared May 24, 1996
EKTACHEM DT LDL CHOLESTEROL KIT
K955904
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 147d

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 declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.