Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K063131
Device Classification Name
Enzyme Immunoassay, Carbamazepine
More FDA Info for this Device
510(K) Number
K063131
Device Name
Enzyme Immunoassay, Carbamazepine
Applicant
THERMO ELECTRON OY
RATASTIE 2
PO BOX 100
VANTAA FIN-01621 FI
Other 510(k) Applications for this Company
Contact
PAIVI SORMUNEN
Other 510(k) Applications for this Contact
Regulation Number
862.3645
More FDA Info for this Regulation Number
Classification Product Code
KLT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/13/2006
Decision Date
10/05/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact