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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, STE 600
WASHINGTON,  DC  20005
Applicant Contact BRUCE F MACKLER
Correspondent
BIOCLONE AUSTRALIA PTY LTD.
C/O MACKLER & GIBBS, P.C.
1120 VERMONT AVE., NW, STE 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
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