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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 K150606
Device Name Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
Applicant
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
M/S 514
Newark,  DE  19714 -6101
Applicant Contact FRANCES A. DILLON
Correspondent
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
M/S 514
Newark,  DE  19714 -6101
Correspondent Contact FRANCES A. DILLON
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DLJ   LAS  
Date Received03/10/2015
Decision Date 10/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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