Medical Device Manufacturer · US , San Diego , CA

Axis-Shield Poc AS - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005
4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - Axis-Shield Poc AS Chemistry ✕

4 devices
1-4 of 4
Cleared Mar 21, 2014
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
K132031 · CHH
Chemistry · 246d
Cleared Feb 15, 2011
AFINION ANALYZER
K110056 · LCP
Chemistry · 36d
Cleared Feb 12, 2008
AFINION ACR AND ACR CONTROL
K072409 · JFY
Chemistry · 169d
Cleared Jul 22, 2005
AFINION HBALC
K050574 · LCP
Chemistry · 137d
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