ClearanceBrief
Panels › Clinical Chemistry › Product code MRR · Class 1

System, Test, Low Density, Lipoprotein

Regulation 862.1475

0510(k)s in 12 months (31 all time)
1recalls in 12 months (9 all time)
8recalls that name a 510(k)
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Top companies in MRR

Company510(k)sRecalls
Beckman Coulter, Inc.13
Reference Diagnostics, Inc.40
Genzyme Corp.30
Siemens Healthcare Diagnostics, Inc.12
Ortho-Clinical Diagnostics, Inc.11
Polymer Technology Systems, Inc.11
Randox Laboratories Limited20
Roche Diagnostics Corp.11
Abbott Laboratories10
Alfa Wassermann, Inc.10
DateFirm and productCodeLinked 510(k)
Nov 6, 2025Beckman Coulter Inc.
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Open, Classified		 MRRNone listed
Aug 29, 2023Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
Open, Classified		 MRRK982529
Oct 8, 2018Ortho-Clinical Diagnostics
VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Terminated		 MRRK041720
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Assay: LDL Cholesterol, Direct
Terminated		 MRRK923504
Jun 27, 2015Roche Diagnostics Operations, Inc.
LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
Terminated		 MRRK012287
Mar 15, 2010Polymer Technology Systems, Inc.
PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitativ
Terminated		 MRRK040693
Oct 9, 2008Roche Diagnostics Corp.
Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for us
Terminated		 MRRK012287
Jul 23, 2004Beckman Coulter Inc
Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No.: 469905 Lot M206161 (level 1) Part No.: 465980 Lot M206192 (level 2) Part No.: 465982 Lot M206194 (level 4) Part No.
Terminated		 MRRK010748
K973696
Jul 20, 2004Beckman Coulter Inc
LDL Cholesterol Reagent (LDLD) Part No. 969706
Terminated		 MRRK014103

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