The following data is part of a premarket notification filed by Cd Diagnostics Inc with the FDA for 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.
| Device ID | K212204 |
| 510k Number | K212204 |
| Device Name: | 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 |
| Classification | Lateral Flow Immunochromatography Assay For Host Infection Biomarkers |
| Applicant | CD Diagnostics Inc 650 Naamans Road Suite 100 Claymont, DE 19703 |
| Contact | Pragnya Bakka |
| Correspondent | Pragnya Bakka CD Diagnostics Inc 650 Naamans Road Suite 100 Claymont, DE 19703 |
| Product Code | QGN |
| CFR Regulation Number | 866.3230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-15 |
| Decision Date | 2021-08-11 |