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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Porphyrin, Spectrophotometry, Lithium
510(k) Number K003583
Device Name LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
Applicant
Trace America, Inc.
845 Ave. G E.
Arlington,  TX  76011
Applicant Contact THOMAS DOLLAR
Correspondent
Trace America, Inc.
845 Ave. G E.
Arlington,  TX  76011
Correspondent Contact THOMAS DOLLAR
Regulation Number862.3560
Classification Product Code
NDW  
Date Received11/20/2000
Decision Date 01/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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