Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K060420
Device Classification Name
Radioimmunoassay, Parathyroid Hormone
More FDA Info for this Device
510(K) Number
K060420
Device Name
Radioimmunoassay, Parathyroid Hormone
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
862.1545
More FDA Info for this Regulation Number
Classification Product Code
CEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/17/2006
Decision Date
03/01/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact