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FDA 510(k) Application Details - K200512
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K200512
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
bioMΘrieux S.A.
376 Chemin de l'Orme
Marcy L'Etoile 69280 FR
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Contact
Alexia Bosquet
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Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
JWY
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More FDA Info for this Product Code
Date Received
03/02/2020
Decision Date
05/07/2020
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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