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FDA 510(k) Application Details - K163298
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K163298
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
Liofilchem s. r. l.
Via Scozia zona ind.le
Roseto degli Abruzzi 64026 IT
Other 510(k) Applications for this Company
Contact
Fabio Brocco
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
JWY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/22/2016
Decision Date
02/22/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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