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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 K962508
Device Name ELECSYS T3
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact LEEANN CHAMBERS
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact LEEANN CHAMBERS
Regulation Number862.1710
Classification Product Code
CDP  
Subsequent Product Code
JIS  
Date Received06/27/1996
Decision Date 08/15/1996
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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