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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 K800054
Device Name KODAK EKTACHEM ELECTROLYTE ANALYZER
Applicant
EASTMAN KODAK COMPANY
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EASTMAN KODAK COMPANY
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1600
Classification Product Code
CEM  
Date Received01/09/1980
Decision Date 02/05/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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