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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 TURNPIKE
BILLERICA,  MA  01865
Applicant Contact ANNE M KULIS
Correspondent
CAMBRIDGE MEDICAL TECHNOLOGY
575 MIDDLESEX TURNPIKE
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
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