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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Diphenylhydantoin
510(k) Number K941142
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
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 Number862.3350
Classification Product Code
DIP  
Date Received03/10/1994
Decision Date 06/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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