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FDA 510(k) Application Details - DEN180032
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN180032
Device Name
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Cont
Applicant
CD Diagnostics Inc.
650 Naamans Road, Suite 100
Claymount, DE 19703 US
Other 510(k) Applications for this Company
Contact
Sujith Kallur
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QGN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/29/2018
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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