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FDA 510(k) Application Details - K072409
Device Classification Name
Enzymatic Method, Creatinine
More FDA Info for this Device
510(K) Number
K072409
Device Name
Enzymatic Method, Creatinine
Applicant
AXIS-SHIELD POC AS
MARSTRANDGATA 6
PO BOX 6863
RODELOKKA, OSLO N-0504 NO
Other 510(k) Applications for this Company
Contact
JORUNN GREVIE LOLLAND
Other 510(k) Applications for this Contact
Regulation Number
862.1225
More FDA Info for this Regulation Number
Classification Product Code
JFY
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More FDA Info for this Product Code
Date Received
08/27/2007
Decision Date
02/12/2008
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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