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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K904483
Device Name ELEGANCE PROLACTIN ELISA
Applicant
Bioclone Australia Pty , Ltd.
C/O Mackler & Gibbs, P.C.
1120 Vermont Ave., NW, Suite 600
Washington,  DC  20005
Applicant Contact BRUCE MACKLER
Correspondent
Bioclone Australia Pty , Ltd.
C/O Mackler & Gibbs, P.C.
1120 Vermont Ave., NW, Suite 600
Washington,  DC  20005
Correspondent Contact BRUCE MACKLER
Regulation Number862.1625
Classification Product Code
CFT  
Date Received10/02/1990
Decision Date 11/05/1990
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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