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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 Selective (Non-Specified)
510(k) Number K900280
Device Name CENTRIPREP 100
Applicant
Amicon, Inc.
17 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact JAMES M DELANEY
Correspondent
Amicon, Inc.
17 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact JAMES M DELANEY
Regulation Number862.2050
Classification Product Code
JJP  
Date Received01/18/1990
Decision Date 02/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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