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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, Potassium
510(k) Number K851100
Device Name CHEM PRO 1000 CHEMISTRY ANALYSIS
Applicant
Sen Tech Medical Corp.
3771 Lexington Ave.
Arden Hills,  MN  55112
Applicant Contact WALTER L SEMBROWICH
Correspondent
Sen Tech Medical Corp.
3771 Lexington Ave.
Arden Hills,  MN  55112
Correspondent Contact WALTER L SEMBROWICH
Regulation Number862.1600
Classification Product Code
CEM  
Date Received03/19/1985
Decision Date 07/09/1985
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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