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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay (Two-Site Solid Phase), Ferritin
510(k) Number K890697
Device Name RIA-GNOST FERRITIN
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 Number866.5340
Classification Product Code
JMG  
Date Received02/10/1989
Decision Date 03/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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