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Panels › Clinical Chemistry › Product code JHM · Class 1

Colorimetric Method, Lipoproteins

Regulation 862.1475

0510(k)s in 12 months (9 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in JHM

Company510(k)sRecalls
Siemens Healthcare Diagnostics14
Dade Behring, Inc.30
Abaxis, Inc.10
Environmental Chemical Specialties10
Jas Diagnostics, Inc.10
Medical Specialties, Inc.10
Roche Diagnostic Systems, Inc.10
DateFirm and productCodeLinked 510(k)
Oct 14, 2022Siemens Healthcare Diagnostics, Inc.
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Open, Classified		 JHMK081300
Feb 3, 2021Siemens Healthcare Diagnostics, Inc.
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the a
Open, Classified		 JHMK081300
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Terminated		 JHMK073072
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
Dimension Assays: Direct HDL Cholesterol (AHDL)
Terminated		 JHMK073072

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