Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K231517
Device Classification Name
System, Test, Carcinoembryonic Antigen
More FDA Info for this Device
510(K) Number
K231517
Device Name
System, Test, Carcinoembryonic Antigen
Applicant
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend CF35 5PZ GB
Other 510(k) Applications for this Company
Contact
Rebecca Lewis
Other 510(k) Applications for this Contact
Regulation Number
866.6010
More FDA Info for this Regulation Number
Classification Product Code
DHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/25/2023
Decision Date
08/23/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact