ClearanceBrief
Panels › Clinical Toxicology › Product code NDW · Class 2

Assay, Porphyrin, Spectrophotometry, Lithium

Regulation 862.3560

0510(k)s in 12 months (7 all time)
0recalls in 12 months (7 all time)
6recalls that name a 510(k)
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Top companies in NDW

Company510(k)sRecalls
Siemens Healthcare Diagnostics14
SENTINEL CH. SpA12
Bayer Healthcare, LLC10
Beckman Coulter Inc01
Diazyme Laboratories, Inc.10
Roche Diagnostics Corp.10
Thermo Electron OY10
Trace America, Inc.10
DateFirm and productCodeLinked 510(k)
Oct 20, 2022Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Open, Classified		 NDWK050374
Oct 20, 2022Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Open, Classified		 NDWK050374
Feb 9, 2022Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Open, Classified		 NDWK050374
Jun 5, 2020Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Calibrator
Terminated		 NDWK050374
Jun 28, 2019Sentinel CH SpA
Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320
Terminated		 NDWK070987
Jun 28, 2019Sentinel CH SpA
MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
Terminated		 NDWK070987
Aug 26, 2006Beckman Coulter Inc
UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
Terminated		 NDWNone listed

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