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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 K840961
Device Name ESCHWEILER COMBI-ANALYSER MTA-500
Applicant
U.S. SCIENCE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
U.S. SCIENCE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1600
Classification Product Code
CEM  
Date Received03/06/1984
Decision Date 08/10/1984
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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