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FDA 510(k) Application Details - K042362
Device Classification Name
Enzymatic, Carbon-Dioxide
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510(K) Number
K042362
Device Name
Enzymatic, Carbon-Dioxide
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN C1E 2A6 CA
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Contact
NANCY OLSCAMP
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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
08/31/2004
Decision Date
12/27/2004
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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