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FDA 510(k) Application Details - K070383
Device Classification Name
Enzymatic Method, Creatinine
More FDA Info for this Device
510(K) Number
K070383
Device Name
Enzymatic Method, Creatinine
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN, P.E.I. C1E 2A6 CA
Other 510(k) Applications for this Company
Contact
DEBBIE M MURRAY
Other 510(k) Applications for this Contact
Regulation Number
862.1225
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Classification Product Code
JFY
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More FDA Info for this Product Code
Date Received
02/09/2007
Decision Date
06/22/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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