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FDA 510(k) Application Details - K073295
Device Classification Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
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510(K) Number
K073295
Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant
THERMO FISHER SCIENTIFIC OY
2 RATASTIE
VANTAA 01620 FI
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Contact
PAIVI SORMUNEN
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Regulation Number
862.1770
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Classification Product Code
CDQ
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Date Received
11/23/2007
Decision Date
05/29/2008
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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