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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, Theophylline
510(k) Number K861367
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
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 Number862.3880
Classification Product Code
KLS  
Date Received04/11/1986
Decision Date 05/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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