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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 K914973
Device Name SYVA EMIT D.A.U. COCAINE METABOLITE
Applicant
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Correspondent Contact PAUL L ROGERS
Regulation Number862.3250
Classification Product Code
DIO  
Date Received11/06/1991
Decision Date 11/29/1991
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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