Medical Device Manufacturer · US , Walker , MI

Iso-Tex Diagnostics - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 1979

Total

Cleared

Denied

Iso-Tex Diagnostics has 2 FDA 510(k) cleared medical devices. Based in Walker, US.

Historical record: 2 cleared submissions from 1979 to 1985. Primary specialty: Chemistry.

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

Iso-Tex Diagnostics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Iso-Tex Diagnostics

3 devices

1-3 of 3

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 28, 2026