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FDA 510(k) Application Details - K172337
Device Classification Name
Panels, Test, Susceptibility, Antimicrobial
More FDA Info for this Device
510(K) Number
K172337
Device Name
Panels, Test, Susceptibility, Antimicrobial
Applicant
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento, CA 95691 US
Other 510(k) Applications for this Company
Contact
Teresa S. Wong
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
LTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2017
Decision Date
12/15/2017
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
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