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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 K943019
Device Name CEDIA T4 MAB ASSAY
Applicant
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Applicant Contact MARY P KONING
Correspondent
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Correspondent Contact MARY P KONING
Regulation Number862.1700
Classification Product Code
KLI  
Date Received06/24/1994
Decision Date 10/20/1994
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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