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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
510(k) Number K010960
Device Name EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
Applicant
Syva Co., Dade Behring, Inc.
P.O. Box 49013
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact SUSAN COLLINS
Correspondent
Syva Co., Dade Behring, Inc.
P.O. Box 49013
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact SUSAN COLLINS
Regulation Number862.3040
Classification Product Code
DIC  
Date Received03/30/2001
Decision Date 04/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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