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
FDA 510(k) clearance DEN180032 · decided 2019-05-23
Clearance details
- K-number
- DEN180032
- 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
- Applicant
- Cd Diagnostics, Inc.
- Decision
- Unknown
- Date received
- 2018-06-29
- Decision date
- 2019-05-23
- Days to decision
- 328 days
- Clearance type
- Direct
- Product code
- QGN
- Device class
- 2
- Regulation number
- 866.3230
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Claymont, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.