510(k) K212204
- Device
- 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
- Applicant
- CD Diagnostics Inc
- 510(k) number
- K212204
- Product code
- QGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-11
- Date received
- 2021-07-15
- Regulation
- 866.3230
- Classification name
- Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Pragnya Bakka
- Address
- 650 Naamans Rd. Suite 100 Claymont DE US 19703 19703
FDA Registration Numbers#
- 3011171357
- 3005360469
Source Documents#
Other 510(k) Records For Product Code QGN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN180032 | 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 | Cd Diagnostics, Inc. | 2019-05-23 |
Legacy Summary#
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FDA Review#
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