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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 K063684
Device Name COBAS LITHIUM
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact THERESA AMBROSE BUSH
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact THERESA AMBROSE BUSH
Regulation Number862.3560
Classification Product Code
NDW  
Subsequent Product Code
JIX  
Date Received12/12/2006
Decision Date 03/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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