Medical Device Manufacturer · US , Claymont , DE

Cd Diagnostics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2019

Recent clearances: 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

View 2 510(k) Devices ↓

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - Cd Diagnostics, Inc. Microbiology ✕

2 devices

1-2 of 2

Cleared Aug 11, 2021

Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha...

Microbiology · 27d

Not Cleared May 23, 2019

Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin...

DEN180032 · QGN

Microbiology · 328d