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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K855169
Device Name T3 UPTAKE RADIOIMMUNOASSAY KIT
Applicant
Cambridge Medical Technology
575 Middlesex Tpke.
Billerica,  MA  01865
Applicant Contact SANDRA L FAN
Correspondent
Cambridge Medical Technology
575 Middlesex Tpke.
Billerica,  MA  01865
Correspondent Contact SANDRA L FAN
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received12/26/1985
Decision Date 02/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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