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FDA 510(k) Application Details - K002694
Device Classification Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
More FDA Info for this Device
510(K) Number
K002694
Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN C1E 2A6 CA
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Contact
KAREN CALLBECK
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
08/29/2000
Decision Date
09/15/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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