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
Decided510(k)Device and applicantCode
Aug 1, 2025K243462Diazyme Colorimetric Lithium Assay
Diazyme Laboratories, Inc.
NDW
Nov 4, 2011K112142DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
Siemens Healthcare Diagnostics
NDW
Mar 21, 2008K063684COBAS LITHIUM
Roche Diagnostics Corp.
NDW
Oct 9, 2007K063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
Thermo Electron OY, FI
NDW
Aug 2, 2007K070987SENTINEL LITHIUM ASSAY
SENTINEL CH. SpA, IT
NDW
Jun 15, 2005K050374ADVIA IMS LITHIUM ASSAY
Bayer Healthcare, LLC
NDW
Jan 17, 2001K003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
Trace America, Inc.
NDW

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