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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Vancomycin
510(k) Number K152245
Device Name ONLINE TDM Vancomycin Gen.3
Applicant
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact BARBARA MCWHORTER
Correspondent
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact BARBARA MCWHORTER
Regulation Number862.3950
Classification Product Code
LEH  
Date Received08/10/2015
Decision Date 01/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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