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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name photometric method, magnesium
510(k) Number K861386
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG)
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Applicant Contact PHILIP J HARTER
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Correspondent Contact PHILIP J HARTER
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received04/14/1986
Decision Date 08/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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