Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K063045
Device Classification Name
Radioimmunoassay, Vancomycin
More FDA Info for this Device
510(K) Number
K063045
Device Name
Radioimmunoassay, Vancomycin
Applicant
DIAGNOSTIC PRODUCTS CORP.
5210 PACIFIC CONCOURCE DR.
LOS ANGELES, CA 90045-6900 US
Other 510(k) Applications for this Company
Contact
DEBORAH L MORRIS
Other 510(k) Applications for this Contact
Regulation Number
862.3950
More FDA Info for this Regulation Number
Classification Product Code
LEH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/04/2006
Decision Date
12/05/2006
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