Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K120056
Device Classification Name
Kappa, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K120056
Device Name
Kappa, Antigen, Antiserum, Control
Applicant
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM, WEST MIDLANDS B15 1QT GB
Other 510(k) Applications for this Company
Contact
JILL CONSTANTINE
Other 510(k) Applications for this Contact
Regulation Number
866.5550
More FDA Info for this Regulation Number
Classification Product Code
DFH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/09/2012
Decision Date
04/01/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact