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FDA 510(k) Application Details - K170491
Device Classification Name
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510(K) Number
K170491
Device Name
Solana C. difficile Assay
Applicant
Quidel Corporation
2005 East State Street, Suite 100
Athens, OH 45701 US
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Contact
Ronald H. Lollar
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Regulation Number
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Classification Product Code
OZN
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Date Received
02/17/2017
Decision Date
05/11/2017
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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