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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 K102647
Device Name ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
Applicant
ELITECHGROUP VITAL SCIENTIFIC BV
21720 23RD DR SE
SUITE 150
BOTHELL,  WA  98021
Applicant Contact DEBRA K HUTSON
Correspondent
ELITECHGROUP VITAL SCIENTIFIC BV
21720 23RD DR SE
SUITE 150
BOTHELL,  WA  98021
Correspondent Contact DEBRA K HUTSON
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   CIT   JIX   JJE  
JJY  
Date Received09/14/2010
Decision Date 03/24/2011
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
Recalls CDRH Recalls
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