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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Immunoreactive Insulin
510(k) Number K890837
Device Name RIA-GNOST INSULIN
Applicant
Cambridge Medical Technology
575 Middlesex Turnpike
Billerica,  MA  01865
Applicant Contact M KRAWCZYK
Correspondent
Cambridge Medical Technology
575 Middlesex Turnpike
Billerica,  MA  01865
Correspondent Contact M KRAWCZYK
Regulation Number862.1405
Classification Product Code
CFP  
Date Received02/21/1989
Decision Date 04/26/1989
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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