FDA 510(k) Application Details - K904387

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K904387
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant BIOCLONE AUSTRALIA PTY LTD.
C/O MACKLER & GIBBS, P.C.
1120 VERMONT AVE., NW, STE 600
WASHINGTON, DC US
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Contact BRUCE F MACKLER
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 09/25/1990
Decision Date 11/06/1990
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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