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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, Digoxin
510(k) Number K983323
Device Name DIGOXIN IMMUNOASSAY
Applicant
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Applicant Contact YUH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Correspondent Contact YUH-GENG TSAY
Regulation Number862.3320
Classification Product Code
KXT  
Subsequent Product Code
DLJ  
Date Received09/22/1998
Decision Date 11/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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