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510(k) K003583

Device
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
Applicant
TRACE AMERICA, INC.
510(k) number
K003583
Product code
NDW  
Decision
Substantially Equivalent (SESE)
Decision date
2001-01-17
Date received
2000-11-20
Regulation
862.3560
Classification name
Assay, Porphyrin, Spectrophotometry, Lithium
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS DOLLAR
Address
845 Ave. G E. Arlington TX US 76011 76011

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NDW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243462Diazyme Colorimetric Lithium AssayDiazyme Laboratories, Inc.2025-08-01
K112142DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics2011-11-04
K063684COBAS LITHIUMRoche Diagnostics Corp.2008-03-21
K063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROLThermo Electron OY2007-10-09
K070987SENTINEL LITHIUM ASSAYSENTINEL CH. SpA2007-08-02
K050374ADVIA IMS LITHIUM ASSAYBayer Healthcare, LLC2005-06-15

Legacy Summary#

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FDA Review#

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