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FDA 510(k) Application Details - K122986
Device Classification Name
Reagent, Borrelia Serological Reagent
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510(K) Number
K122986
Device Name
Reagent, Borrelia Serological Reagent
Applicant
BIOMERIEUX SA
CHEMIN DE L ORME
MARCY L ETOILE 69280 FR
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Contact
CATHERINE FRITSCH
Other 510(k) Applications for this Contact
Regulation Number
866.3830
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Classification Product Code
LSR
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More FDA Info for this Product Code
Date Received
09/26/2012
Decision Date
03/05/2013
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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