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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, N-Acetylprocainamide
510(k) Number K871680
Device Name MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
Applicant
Roche Diagnostic Systems, Inc.
Div. Of Hoffmann-La Roche, Inc
Nutley,  NJ  07110
Applicant Contact KAFADER II
Correspondent
Roche Diagnostic Systems, Inc.
Div. Of Hoffmann-La Roche, Inc
Nutley,  NJ  07110
Correspondent Contact KAFADER II
Regulation Number862.3320
Classification Product Code
LAN  
Date Received04/29/1987
Decision Date 06/08/1987
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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