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— 510(k) K212204
Substantially EquivalentCd Diagnostics, Inc.
FDA 510(k) clearance K212204 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 Control Kit, Substantially Equivalent on 2021-08-11. Applicant: Cd Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Cd Diagnostics, Inc.
- Product code
- Code QGN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3230
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Claymont, DE, US
Recent devices under product code QGN
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