Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - DEN160016
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN160016
Device Name
Variola virus Real-Time PCR Assay
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
1600 CLIFTON ROAD NE, MS-C18
ATLANTA, GA 30329 US
Other 510(k) Applications for this Company
Contact
YON YU
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PRA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2016
Decision Date
02/06/2017
Decision
DENG -
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact