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FDA 510(k) Application Details - K072686
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K072686
Device Name
Assay, Glycosylated Hemoglobin
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE, SCOTLAND DD2 1XA GB
Other 510(k) Applications for this Company
Contact
Claire Dora
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
09/24/2007
Decision Date
03/17/2008
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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