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FDA 510(k) Application Details - K973109
Device Classification Name
Diazo Colorimetry, Bilirubin
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510(K) Number
K973109
Device Name
Diazo Colorimetry, Bilirubin
Applicant
SYNERMED, INC.
1688 50TH AVENUE,
MONTREAL (LACHINE),
QUEBEC, CANADA H8T 2V5 CA
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Contact
MARCIA J ARENTZ
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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
08/19/1997
Decision Date
09/25/1997
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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