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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 K874576
Device Name KODAK EKTACHEM DT SLIDES (MG)
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact NORMAN H GEIL
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact NORMAN H GEIL
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received11/06/1987
Decision Date 01/21/1988
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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