Medical Device Manufacturer · US , Bridgewater , NJ

Direct Access Diagnostics - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1996
2
Total
2
Cleared
0
Denied

Direct Access Diagnostics has 2 FDA 510(k) cleared medical devices. Based in Bridgewater, US.

Historical record: 2 cleared submissions from 1996 to 1996. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Direct Access Diagnostics Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Direct Access Diagnostics

2 devices
1-2 of 2
Cleared Nov 18, 1996
FACT PLUS PREGNANCY TEST
K964108 · LCX
Chemistry · 34d
Cleared Jul 29, 1996
FACTPLUS ONE STEP PREGNANCY TEST
K962521 · LCX
Chemistry · 40d
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