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FDA 510(k) Application Details - K923506

Device Classification Name Urease And Glutamic Dehydrogenase, Urea Nitrogen

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510(K) Number K923506
Device Name Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, BT29 4QY CO.
ANTRIM, N. IRELAND IR
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Contact JOHN LAMONT
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Regulation Number 862.1770

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Classification Product Code CDQ
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Date Received 07/15/1992
Decision Date 09/27/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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