Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K132843
Device Classification Name
More FDA Info for this Device
510(K) Number
K132843
Device Name
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
Applicant
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
NORTHBROOK, IL 60062 US
Other 510(k) Applications for this Company
Contact
MARK DEL VECCHIO
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/10/2013
Decision Date
01/08/2014
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