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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K840606
Device Name EKTACHEM CLINICAL CHEM. SLIDES
Applicant
Eastman Kodak Company
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Eastman Kodak Company
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1110
Classification Product Code
CIG  
Date Received02/10/1984
Decision Date 04/04/1984
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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