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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, Procainamide
510(k) Number K962463
Device Name PROCAINAMIDE ENZYME IMMUNOASSAY
Applicant
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Applicant Contact YUH-GENG TSAY,PH.D.
Correspondent
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Correspondent Contact YUH-GENG TSAY,PH.D.
Regulation Number862.3320
Classification Product Code
LAR  
Date Received06/25/1996
Decision Date 08/14/1996
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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