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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, Digoxin
510(k) Number K854638
Device Name CEDIA DIGOXIN ASSAY
Applicant
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Applicant Contact DANIEL HENDERSON
Correspondent
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Correspondent Contact DANIEL HENDERSON
Regulation Number862.3320
Classification Product Code
KXT  
Date Received11/19/1985
Decision Date 03/25/1986
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
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