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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K854426
Device Name KODAK EKTACHEM HDL CHOLESTEROL KIT
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 Number862.1175
Classification Product Code
CHH  
Date Received11/05/1985
Decision Date 01/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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