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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, Non-Radiolabeled, Total Thyroxine
510(k) Number K884634
Device Name MODIFIED CEDIA TOTAL T4 ASSAY
Applicant
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Applicant Contact ROBERT K PIGOZZI
Correspondent
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Correspondent Contact ROBERT K PIGOZZI
Regulation Number862.1700
Classification Product Code
KLI  
Date Received11/07/1988
Decision Date 12/09/1988
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
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