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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 K873737
Device Name NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY
Applicant
Cambridge Medical Technology
575 Middlesex Tpke.
Billerica,  MA  01865
Applicant Contact ANNE M KULIS
Correspondent
Cambridge Medical Technology
575 Middlesex Tpke.
Billerica,  MA  01865
Correspondent Contact ANNE M KULIS
Regulation Number862.1710
Classification Product Code
CDP  
Date Received09/15/1987
Decision Date 11/24/1987
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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