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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
510(k) Number K843824
Device Name COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
Applicant
Roche Diagnostic Systems, Inc.
Nutley,  NJ  07110 -
Applicant Contact GRIFFIN FITZGERALD
Correspondent
Roche Diagnostic Systems, Inc.
Nutley,  NJ  07110 -
Correspondent Contact GRIFFIN FITZGERALD
Regulation Number862.3350
Classification Product Code
LGR  
Date Received09/28/1984
Decision Date 02/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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