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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Testosterones And Dihydrotestosterone
510(k) Number K915164
Device Name SRI TESTOSTERONE ENZYME IMMUNOASSAY
Applicant
SERONO-BAKER DIAGNOSTICS, INC.
100 CASCADE DR.
ALLENTOWN,  PA  18103 -9562
Applicant Contact DAVID B THOMAS
Correspondent
SERONO-BAKER DIAGNOSTICS, INC.
100 CASCADE DR.
ALLENTOWN,  PA  18103 -9562
Correspondent Contact DAVID B THOMAS
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received11/14/1991
Decision Date 03/02/1992
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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