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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, Cannabinoids
510(k) Number K011300
Device Name EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
Applicant
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact VIRGINIA SINGER
Correspondent
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact VIRGINIA SINGER
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received04/30/2001
Decision Date 05/17/2001
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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