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FDA 510(k) Application Details - K974337
Device Classification Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
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510(K) Number
K974337
Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON, MA 02173 US
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Contact
CAROL MARBLE
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Regulation Number
862.1770
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Classification Product Code
CDQ
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Date Received
11/18/1997
Decision Date
12/17/1997
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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