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FDA 510(k) Application Details - K212461
Device Classification Name
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510(K) Number
K212461
Device Name
VITEK MS PRIME
Applicant
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood, MO 63042 US
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Contact
Nathan Hardesty
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Regulation Number
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Classification Product Code
QBN
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Date Received
08/06/2021
Decision Date
03/15/2022
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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