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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colorimetry, salicylate
510(k) Number K961131
Device Name SALICYLATE ASSAY
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 Number862.3830
Classification Product Code
DKJ  
Date Received03/21/1996
Decision Date 04/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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