Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K142033
Device Classification Name
More FDA Info for this Device
510(K) Number
K142033
Device Name
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
Applicant
NANOSPERE,INC.
4088 COMMERCIAL AVE
NORTHBROOK, IL 60062 US
Other 510(k) Applications for this Company
Contact
NOAH LERMER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PCH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/25/2014
Decision Date
10/10/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact