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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, Cocaine And Cocaine Metabolites
510(k) Number K993988
Device Name SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
Applicant
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Correspondent Contact PAUL L ROGERS
Regulation Number862.3250
Classification Product Code
DIO  
Date Received11/24/1999
Decision Date 01/27/2000
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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