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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Calcitonin
510(k) Number K781909
Device Name CALCITONIN 125
Applicant
Cambridge Nuclear Radiopharmaceutical
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cambridge Nuclear Radiopharmaceutical
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1140
Classification Product Code
JKR  
Date Received11/14/1978
Decision Date 01/10/1979
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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