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FDA 510(k) Application Details - K080435
Device Classification Name
Diazo Colorimetry, Bilirubin
More FDA Info for this Device
510(K) Number
K080435
Device Name
Diazo Colorimetry, Bilirubin
Applicant
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
3500 CORPORATE PKWAY
CENTER VALLEY, PA 18034 US
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Contact
STEPHANIE G DONNELLY
Other 510(k) Applications for this Contact
Regulation Number
862.1110
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Classification Product Code
CIG
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More FDA Info for this Product Code
Date Received
02/19/2008
Decision Date
09/05/2008
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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