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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 K992842
Device Name HICHEM ISE ELECTROLYTE REFERENCE
Applicant
Elan Holdings, Inc.
231 N. Puente St.
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Elan Holdings, Inc.
231 N. Puente St.
Brea,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   JFL   JFP  
Date Received08/24/1999
Decision Date 11/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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