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FDA 510(k) Application Details - K001574
Device Classification Name
System, Test, Anticardiolipin Immunological
More FDA Info for this Device
510(K) Number
K001574
Device Name
System, Test, Anticardiolipin Immunological
Applicant
AXIS-SHIELD
THE TECHNOLOGY PARK
JUNA PLACE
DUNDEE TAYSIDE, SCOTLAND DD2 1XA GB
Other 510(k) Applications for this Company
Contact
EILEEN A MCCAFFERTY
Other 510(k) Applications for this Contact
Regulation Number
866.5660
More FDA Info for this Regulation Number
Classification Product Code
MID
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/22/2000
Decision Date
06/09/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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