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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, Carbamazepine
510(k) Number K031902
Device Name ONLINE TDM CARBAMAZEPINE
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact KERWIN KAUFMAN
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact KERWIN KAUFMAN
Regulation Number862.3645
Classification Product Code
KLT  
Date Received06/20/2003
Decision Date 09/17/2003
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
Predetermined Change
Control Plan Authorized		 No
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