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FDA 510(k) Application Details - K983019
Device Classification Name
Enzymatic, Carbon-Dioxide
More FDA Info for this Device
510(K) Number
K983019
Device Name
Enzymatic, Carbon-Dioxide
Applicant
DIAGNOSTIC CHEMICALS LTD.
WEST ROYALTY INDUSTRIAL PARK,
CHARLOTTETOWN, P.E.I. C1E 2A6 CA
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Contact
KAREN CALLBECK
Other 510(k) Applications for this Contact
Regulation Number
862.1160
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Classification Product Code
KHS
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More FDA Info for this Product Code
Date Received
08/31/1998
Decision Date
09/14/1998
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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