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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, digitoxin
510(k) Number K942610
Device Name KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
Applicant
EASTMAN KODAK COMPANY
1669 LAKE AVE.
ROCHESTER,  NY  14652
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
EASTMAN KODAK COMPANY
1669 LAKE AVE.
ROCHESTER,  NY  14652
Correspondent Contact YVONNE E MIDDLEFELL
Regulation Number862.3300
Classification Product Code
LFM  
Date Received06/02/1994
Decision Date 10/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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