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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K895840
Device Name MILENIA(TM) TOTAL T4 (MKT41,5)
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact B ASARCH
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact B ASARCH
Regulation Number862.1710
Classification Product Code
CDP  
Date Received10/03/1989
Decision Date 10/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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