Medical Device Manufacturer · US , Mchenry , IL

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

12 submissions · 12 cleared · Since 1979

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - United Diagnostics, Inc. Chemistry ✕

9 devices

1-9 of 9

Cleared Jan 27, 1989

Chemistry · 58d

Cleared Aug 04, 1986

Chemistry · 49d

Cleared Nov 27, 1984

STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3

Chemistry · 47d

Cleared Nov 27, 1984

GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3

Chemistry · 47d

Cleared Aug 10, 1983

STAT-TRAK LIQUID ELECTROLYTE CONTROL

Chemistry · 103d

Cleared Jun 22, 1983

BLOOD GAS & FLAME PHOTOMETER INSTRU-

Chemistry · 79d

Cleared Apr 01, 1982

GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL

Chemistry · 16d

Cleared Dec 31, 1981

BLOOD GAS ANALYSIS, STANDARDS CONTROLS

Chemistry · 15d

Cleared Nov 13, 1979

GAS-TRAK BLOOD GAS CONTROL

Chemistry · 25d