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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K904387
Device Name BIOCLONES ELEGANCE LH ELISA KIT
Applicant
Bioclone Australia Pty , Ltd.
C/O Mackler & Gibbs, P.C.
1120 Vermont Ave., NW, Suite 600
Washington,  DC  20005
Applicant Contact BRUCE F MACKLER
Correspondent
Bioclone Australia Pty , Ltd.
C/O Mackler & Gibbs, P.C.
1120 Vermont Ave., NW, Suite 600
Washington,  DC  20005
Correspondent Contact BRUCE F MACKLER
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/25/1990
Decision Date 11/06/1990
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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