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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 K171476
Device Name SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
Applicant
Awareness Technology, Inc.
1935 S.W Martin Hwy.
Palm City,  FL  34990
Applicant Contact Steve Andrus
Correspondent
Awareness Technology, Inc.
1935 S.W Martin Hwy.
Palm City,  FL  34990
Correspondent Contact Steve Andrus
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   JJE  
Date Received05/19/2017
Decision Date 02/27/2018
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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