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FDA 510(k) Application Details - K974909
Device Classification Name
Alkaline Picrate, Colorimetry, Creatinine
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510(K) Number
K974909
Device Name
Alkaline Picrate, Colorimetry, Creatinine
Applicant
SYNERMED INTL., INC.
1688 50TH AVE.
LACHINE, QUEBEC H8T 2V5 CA
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Contact
MARCIA J ARENTZ
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Regulation Number
862.1225
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Classification Product Code
CGX
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More FDA Info for this Product Code
Date Received
12/31/1997
Decision Date
02/24/1998
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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