Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K050748
Device Classification Name
Radioimmunoassay, Acth
More FDA Info for this Device
510(K) Number
K050748
Device Name
Radioimmunoassay, Acth
Applicant
SCANTIBODIES LABORATORY, INC.
9336 ABRAHAM WAY
SANTEE, CA 92071 US
Other 510(k) Applications for this Company
Contact
MICHAEL NORDSTROM
Other 510(k) Applications for this Contact
Regulation Number
862.1025
More FDA Info for this Regulation Number
Classification Product Code
CKG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/2005
Decision Date
05/20/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact