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FDA 510(k) Application Details - K981106
Device Classification Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
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510(K) Number
K981106
Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant
TECO DIAGNOSTICS
4925 EAST HUNTER AVE.
ANAHEIM, CA 92807 US
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Contact
RHODA FILIPINA
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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
03/26/1998
Decision Date
04/16/1998
Decision
SESE - SUBST EQUIV
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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