Medical Device Manufacturer · US , Walker , MI

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

3 submissions · 2 cleared · Since 1979

3

Total

2

Cleared

0

Denied

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

2 devices

1-2 of 2

Cleared Jan 10, 1984

APO A-I RIA KIT-HUMAN PLASMA APOLIP-

Cleared Mar 21, 1979

RIA SYSTEM, PARATHYROID HORMONE

Chemistry · 98d

Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Apr 28, 2026