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FDA 510(k) Application Details - DEN180069
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN180069
Device Name
ZIKV Detect 2.0 IgM Capture ELISA
Applicant
InBios International, Inc.
307 Westlake Ave N, Suite 300
Seattle, WA 98109 US
Other 510(k) Applications for this Company
Contact
Estela Raychaudhuri
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QFO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2018
Decision Date
05/23/2019
Decision
DENG -
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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