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FDA 510(k) Application Details - K030741
Device Classification Name
System, Test, Anticardiolipin Immunological
More FDA Info for this Device
510(K) Number
K030741
Device Name
System, Test, Anticardiolipin Immunological
Applicant
HYCOR BIOMEDICAL LTD.
PENTLANDS SCIENCE PARK
BUSH LOAN
EDINBURGH EH26 OPL GB
Other 510(k) Applications for this Company
Contact
DANIELLE M KNIGHT
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
03/10/2003
Decision Date
05/01/2003
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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