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FDA 510(k) Application Details - K140354
Device Classification Name
Dna-Reagents, Neisseria
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510(K) Number
K140354
Device Name
Dna-Reagents, Neisseria
Applicant
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018 US
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Contact
STACY FERGUSON
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Regulation Number
866.3390
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Classification Product Code
LSL
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More FDA Info for this Product Code
Date Received
02/12/2014
Decision Date
05/09/2014
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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