Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K173653
Device Classification Name
More FDA Info for this Device
510(K) Number
K173653
Device Name
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
Applicant
Alere Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074 US
Other 510(k) Applications for this Company
Contact
Danielle A. Briggeman
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/28/2017
Decision Date
05/02/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Dual Track
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact