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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, Methadone
510(k) Number K994005
Device Name SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
Applicant
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161 -9013
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161 -9013
Correspondent Contact PAUL L ROGERS
Regulation Number862.3620
Classification Product Code
DJR  
Date Received11/24/1999
Decision Date 01/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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