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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 Thyroxine
510(k) Number K922945
Device Name TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
Applicant
HERAEUS KULZER, INC.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact ROBERT L HABIG
Correspondent
HERAEUS KULZER, INC.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact ROBERT L HABIG
Regulation Number862.1700
Classification Product Code
CDX  
Date Received06/18/1992
Decision Date 10/14/1992
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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