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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 K011878
Device Name EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
Applicant
Syva Co.
20400 Mariani Ave.
Cupertino,  CA  95014
Applicant Contact SUSAN L COLLINS
Correspondent
Syva Co.
20400 Mariani Ave.
Cupertino,  CA  95014
Correspondent Contact SUSAN L COLLINS
Regulation Number862.3830
Classification Product Code
DKJ  
Subsequent Product Code
DLJ  
Date Received06/15/2001
Decision Date 08/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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