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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estrone
510(k) Number K864966
Device Name ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
Applicant
Diagnostics Biochem Canada, Inc.
1020 Hargrieve Rd.
London, Ontario,  CA N6E 1P5
Correspondent
Diagnostics Biochem Canada, Inc.
1020 Hargrieve Rd.
London, Ontario,  CA N6E 1P5
Regulation Number862.1280
Classification Product Code
CGF  
Date Received12/22/1986
Decision Date 01/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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