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FDA 510(k) Application Details - K992800
Device Classification Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
More FDA Info for this Device
510(K) Number
K992800
Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS, MO 63103 US
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Contact
WILLIAM R GILBERT
Other 510(k) Applications for this Contact
Regulation Number
862.1770
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Classification Product Code
CDQ
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More FDA Info for this Product Code
Date Received
08/19/1999
Decision Date
09/28/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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