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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, Barbiturate
510(k) Number K960664
Device Name BARBITURATE SERUM TOX EIA ASSAY
Applicant
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Applicant Contact YUG-GENG TSAY, PH.D.
Correspondent
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Correspondent Contact YUG-GENG TSAY, PH.D.
Regulation Number862.3150
Classification Product Code
DIS  
Date Received02/16/1996
Decision Date 05/06/1996
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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