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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Colorimetric Method, Cpk Or Isoenzymes
510(k) Number K875192
Device Name KODAK EKTACHEM DT SLIDES (CKMB)
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Applicant Contact JOHN FERGUSON
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Correspondent Contact JOHN FERGUSON
Regulation Number862.1215
Classification Product Code
JHY  
Date Received12/17/1987
Decision Date 02/24/1988
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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