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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Androstenedione
510(k) Number K801729
Device Name ANDROSTENEDIONE RADIOIMMUNOASSAY KIT
Applicant
DIAGNOSTICS BIOCHEM CANADA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DIAGNOSTICS BIOCHEM CANADA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1075
Classification Product Code
CIZ  
Date Received07/24/1980
Decision Date 10/31/1980
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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