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 Control Kit

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

CD Diagnostics Inc.

The following data is part of a De Novo classification by Cd Diagnostics Inc. with the FDA for 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 Control Kit.

Pre-market Notification Details

DeNovo IDDEN180032
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 Control Kit
ClassificationLateral Flow Immunochromatography Assay For Host Infection Biomarkers
Applicant CD Diagnostics Inc. 650 Naamans Road, Suite 100 Claymount,  DE  19703
ContactSujith Kallur
Product CodeQGN  
CFR Regulation Number866.3230 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypeDirect
Date Received2018-06-29
Decision Date2019-05-23
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868358852 DEN180032 000
00887868358845 DEN180032 000
00887868358838 DEN180032 000
00887868358821 DEN180032 000
00887868358814 DEN180032 000

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