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Panels › Clinical Chemistry › Product code JFM · Class 2

Enzymatic Method, Bilirubin

Regulation 862.1110

0510(k)s in 12 months (11 all time)
0recalls in 12 months (9 all time)
6recalls that name a 510(k)
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Top companies in JFM

Company510(k)sRecalls
Siemens Healthcare Diagnostics, Inc.18
Randox Laboratories Limited21
Wako Chemicals USA, Inc.30
Bayer Healthcare, LLC10
Beckman Coulter, Inc.10
Beckman Instruments, Inc.10
Diagnostic Chemicals, Ltd. (Usa)10
Stanbio Laboratory10
DateFirm and productCodeLinked 510(k)
Dec 6, 2023Randox Laboratories Ltd.
RANDOX Total Bilirubin.
Open, Classified		 JFMK152344
Aug 28, 2023Siemens Healthcare Diagnostics, Inc.
Atellica CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Ma
Open, Classified		 JFMNone listed
Aug 28, 2023Siemens Healthcare Diagnostics, Inc.
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Mater
Open, Classified		 JFMNone listed
Aug 28, 2023Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Mater
Open, Classified		 JFMNone listed
Aug 28, 2023Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemen
Open, Classified		 JFMK170065
Feb 13, 2020Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in
Terminated		 JFMK170065
Feb 13, 2020Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin i
Terminated		 JFMK053132
Feb 13, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitativ
Terminated		 JFMK053131
Feb 13, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative deter
Terminated		 JFMK053132

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