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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 K962760
Device Name ENZYMUN-TEST FT3
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact JOHN D STEVENS
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact JOHN D STEVENS
Regulation Number862.1710
Classification Product Code
CDP  
Date Received07/16/1996
Decision Date 11/29/1996
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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