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FDA 510(k) Application Details - K180936
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K180936
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
bioMerieux SA
376 Chemin de l'Orme
Marcy L'Etoile 69280 FR
Other 510(k) Applications for this Company
Contact
Asa Karlsson
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
04/10/2018
Decision Date
07/03/2018
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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