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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Differential Rate Kinetic Method, Cpk Or Isoenzymes
510(k) Number K861387
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
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 Number862.1215
Classification Product Code
JHS  
Date Received04/14/1986
Decision Date 06/27/1986
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
Recalls CDRH Recalls
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