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FDA 510(k) Application Details - K150868
Device Classification Name
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510(K) Number
K150868
Device Name
Solana GAS Assay, Solana instrument
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
PGX
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Date Received
04/01/2015
Decision Date
06/23/2015
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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