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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
510(k) Number K932729
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS)
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact BRADFORD M SPRING
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact BRADFORD M SPRING
Regulation Number862.1580
Classification Product Code
CEO  
Date Received06/07/1993
Decision Date 08/03/1993
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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