Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K021516
Device Classification Name
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
More FDA Info for this Device
510(K) Number
K021516
Device Name
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
LUNA PLACE
DUNDEE, SCOTLAND DD2 1XA GB
Other 510(k) Applications for this Company
Contact
EILEEN MCCAFFERTY
Other 510(k) Applications for this Contact
Regulation Number
866.5775
More FDA Info for this Regulation Number
Classification Product Code
NHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/10/2002
Decision Date
07/23/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact