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FDA 510(k) Application Details - DEN120008
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN120008
Device Name
STRATIFY JCV(TM) ANTIBODY
Applicant
FOCUS DIAGNOSTICS, INC.
11331 VALLEY VIEW ST.
CYPRESS, CA 90630 US
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Contact
TARA VIVIANI
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OYP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2012
Decision Date
01/20/2012
Decision
DENG -
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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