Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K200215
Device Classification Name
System, Test, Carcinoembryonic Antigen
More FDA Info for this Device
510(K) Number
K200215
Device Name
System, Test, Carcinoembryonic Antigen
Applicant
Siemens Healthcare Disgnostics Inc.
511 Benedict Ave.
Tarrytown, NY 10591 US
Other 510(k) Applications for this Company
Contact
Mey Lyn Vasquez
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
01/28/2020
Decision Date
04/13/2020
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