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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 K172416
Device Name Synermed Opiate Enzyme Immunoassay
Applicant
Infrared Laboratory Systems, LLC (Dba Synermed)
17408 Tiller Ct. Suite 1900
Westfield,  IN  40674
Applicant Contact Julie Paschal
Correspondent
Infrared Laboratory Systems, LLC (Dba Synermed)
17408 Tiller Ct. Suite 1900
Westfield,  IN  40674
Correspondent Contact Julie Paschal
Regulation Number862.3650
Classification Product Code
DJG  
Date Received08/10/2017
Decision Date 04/19/2018
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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