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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic method, alcohol dehydrogenase, ultraviolet
510(k) Number K934273
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
Applicant
EASTMAN KODAK COMPANY
100 INDIGO CREEK DR.
ROCHESTER,  NY  14652 -0882
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
EASTMAN KODAK COMPANY
100 INDIGO CREEK DR.
ROCHESTER,  NY  14652 -0882
Correspondent Contact YVONNE E MIDDLEFELL
Regulation Number862.3040
Classification Product Code
DMT  
Date Received08/31/1993
Decision Date 03/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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