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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K850254
Device Name PARATHYROID HORMONE RADIOIMMUNOASSAY KIT
Applicant
Cambridge Medical Technology
575 Middlesex Tpke.
Billerica,  MA  01865
Applicant Contact CAROLE VARANELLI
Correspondent
Cambridge Medical Technology
575 Middlesex Tpke.
Billerica,  MA  01865
Correspondent Contact CAROLE VARANELLI
Regulation Number862.1545
Classification Product Code
CEW  
Date Received01/22/1985
Decision Date 04/03/1985
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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