Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K190204
Device Classification Name
More FDA Info for this Device
510(K) Number
K190204
Device Name
ID NOW Influenza A & B 2
Applicant
Alere Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074 US
Other 510(k) Applications for this Company
Contact
Angela Drysdale
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/04/2019
Decision Date
03/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact