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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amikacin Serum Assay
510(k) Number K032279
Device Name ONLINE TDM AMIKA
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 Number862.3035
Classification Product Code
KLP  
Date Received07/24/2003
Decision Date 10/10/2003
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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