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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 K901759
Device Name COBAS-FP REAGENTS FOR VANCOMYCIN
Applicant
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Applicant Contact ALEX WESOLOWSKI
Correspondent
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Correspondent Contact ALEX WESOLOWSKI
Regulation Number862.3950
Classification Product Code
LEH  
Date Received04/18/1990
Decision Date 05/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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