Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K063425
Device Classification Name
Ige, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K063425
Device Name
Ige, Antigen, Antiserum, Control
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,, DE 19714 US
Other 510(k) Applications for this Company
Contact
KATHLEEN DRAY-LYONS
Other 510(k) Applications for this Contact
Regulation Number
866.5510
More FDA Info for this Regulation Number
Classification Product Code
DGC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/2006
Decision Date
02/15/2007
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