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FDA 510(k) Application Details - K091260
Device Classification Name
Epstein-Barr Virus, Other
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510(K) Number
K091260
Device Name
Epstein-Barr Virus, Other
Applicant
QUEST INTL., INC.
8127 N.W. 29TH STREET
DORAL, FL 33122 US
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Contact
DAVID J KIEFER
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Regulation Number
866.3235
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Classification Product Code
LSE
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More FDA Info for this Product Code
Date Received
04/29/2009
Decision Date
06/08/2009
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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