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FDA 510(k) Application Details - K230863
Device Classification Name
Reagent, Borrelia Serological Reagent
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510(K) Number
K230863
Device Name
Reagent, Borrelia Serological Reagent
Applicant
ZEUS Scientific
200 Evans Way
Branchburg, NJ 08876 US
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Contact
Mark Kopnitsky
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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
03/29/2023
Decision Date
07/13/2023
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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