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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K914835
Device Name LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
Applicant
LONDON DIAGNOSTICS, INC.
10300 VALLEY VIEW RD.
SUITE 107
EDEN PRAIRIE,  MN  55344
Applicant Contact K RAMAKRISHNAN
Correspondent
LONDON DIAGNOSTICS, INC.
10300 VALLEY VIEW RD.
SUITE 107
EDEN PRAIRIE,  MN  55344
Correspondent Contact K RAMAKRISHNAN
Regulation Number862.1695
Classification Product Code
CEC  
Date Received10/25/1991
Decision Date 12/17/1991
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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