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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, Opiates
510(k) Number K011289
Device Name EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
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 Number862.3650
Classification Product Code
DJG  
Date Received04/27/2001
Decision Date 05/15/2001
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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