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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
510(k) Number K934358
Device Name KODAK EKTACHEM DT SLIDES (FE)
Applicant
Eastman Kodak Company
100 Indigo Creek Dr.
Rochester,  NY  14652
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
Eastman Kodak Company
100 Indigo Creek Dr.
Rochester,  NY  14652
Correspondent Contact YVONNE E MIDDLEFELL
Regulation Number862.1415
Classification Product Code
JQE  
Date Received09/08/1993
Decision Date 03/21/1994
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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