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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 K051646
Device Name ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
Applicant
Pointe Scientific, Inc.,
5449 Research Dr.
Lincoln Park,  MI  48188
Applicant Contact WILLIAM F WALTERS
Correspondent
Pointe Scientific, Inc.,
5449 Research Dr.
Lincoln Park,  MI  48188
Correspondent Contact WILLIAM F WALTERS
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ  
Date Received06/21/2005
Decision Date 10/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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