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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay, Primidone
510(k) Number K852318
Device Name COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
Applicant
Roche Diagnostic Systems, Inc.
Div. Of Hoffmann-La Roche, Inc
Nutley,  NJ  07110
Applicant Contact DONALD KAFADER
Correspondent
Roche Diagnostic Systems, Inc.
Div. Of Hoffmann-La Roche, Inc
Nutley,  NJ  07110
Correspondent Contact DONALD KAFADER
Regulation Number862.3680
Classification Product Code
LFT  
Date Received05/31/1985
Decision Date 06/25/1985
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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