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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K872447
Device Name CEDIA(TM) T UPTAKE
Applicant
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Applicant Contact B FRIEDMAN
Correspondent
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Correspondent Contact B FRIEDMAN
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received06/23/1987
Decision Date 08/21/1987
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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