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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, n-acetylprocainamide
510(k) Number K060738
Device Name TDM N-ACETYLPROCAINAMIDE
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact DIMITRIS DEMIRTZOGLOU
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact DIMITRIS DEMIRTZOGLOU
Regulation Number862.3320
Classification Product Code
LAN  
Date Received03/20/2006
Decision Date 08/16/2006
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
Recalls CDRH Recalls
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