510(k) DEN180032
- Device
- 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
- Applicant
- Cd Diagnostics, Inc.
- 510(k) number
- DEN180032
- Product code
- QGN
- Decision
- Unknown (DENG)
- Decision date
- 2019-05-23
- Date received
- 2018-06-29
- Regulation
- 866.3230
- Classification name
- Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sujith Kallur
- Address
- 650 Naamans Rd. Suite 100 Claymont DE US 19703 19703
FDA Registration Numbers#
- 3011171357
- 3005360469
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QGN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212204 | Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit | Cd Diagnostics, Inc. | 2021-08-11 |