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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, Gentamicin
510(k) Number K020704
Device Name ROCHE ONLINE GENTAMICIN
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact MIKE FLIS
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact MIKE FLIS
Regulation Number862.3450
Classification Product Code
LCD  
Date Received03/04/2002
Decision Date 07/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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