Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113181
Device Classification Name
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
More FDA Info for this Device
510(K) Number
K113181
Device Name
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Applicant
VERIDEX, LLC
1001 US HIGHWAY 202 NORTH
RARITAN, NJ 08869-0606 US
Other 510(k) Applications for this Company
Contact
PATRICIA HOJNOSKI
Other 510(k) Applications for this Contact
Regulation Number
866.6020
More FDA Info for this Regulation Number
Classification Product Code
NQI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/28/2011
Decision Date
12/12/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact