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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name starch-dye bound polymer, amylase
510(k) Number K812027
Device Name KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
Applicant
EASTMAN KODAK COMPANY
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EASTMAN KODAK COMPANY
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1070
Classification Product Code
CIW  
Date Received07/20/1981
Decision Date 08/03/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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