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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 K961490
Device Name ELECSYS T4 ASSAY
Applicant
BOEHRINGER MANNHEIM CORP.
2400 BISSO LN.
P.O. BOX 4117
CONCORD,  CA  94524 -4117
Applicant Contact MARY KONING
Correspondent
BOEHRINGER MANNHEIM CORP.
2400 BISSO LN.
P.O. BOX 4117
CONCORD,  CA  94524 -4117
Correspondent Contact MARY KONING
Regulation Number862.1700
Classification Product Code
CDX  
Date Received04/18/1996
Decision Date 06/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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