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FDA 510(k) Application Details - K110056
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K110056
Device Name
Assay, Glycosylated Hemoglobin
Applicant
AXIS-SHIELD POC AS
P.O. BOX 6863
RODELOKKA
OSLO N-0504 NO
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Contact
KARI SKINNEMOEN
Other 510(k) Applications for this Contact
Regulation Number
864.7470
More FDA Info for this Regulation Number
Classification Product Code
LCP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2011
Decision Date
02/15/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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