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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 K221605
Device Name Emit® II Plus Buprenorphine Assay
Applicant
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr., P.O. Box 6101
Mail Stop 514
Newark,  DE  19714
Applicant Contact Julie Warren
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr., P.O. Box 6101
Mail Stop 514
Newark,  DE  19714
Correspondent Contact Julie Warren
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Code
JJE  
Date Received06/02/2022
Decision Date 07/25/2023
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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