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FDA 510(k) Application Details - K192050
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K192050
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
bioMerieux SA
376 Chemin de lÆOrme
Marcy-lÆEtoile 69280 FR
Other 510(k) Applications for this Company
Contact
Marine Taravant
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
07/31/2019
Decision Date
09/27/2019
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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