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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K181201
Device Name Synermed ISE Reagents
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 Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ  
Date Received05/07/2018
Decision Date 07/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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