Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K171792
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
More FDA Info for this Device
510(K) Number
K171792
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
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
866.3980
More FDA Info for this Regulation Number
Classification Product Code
OCC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2017
Decision Date
09/29/2017
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