Medical Device Manufacturer · US , Mchenry , IL

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

16 submissions · 16 cleared · Since 1984

16

Total

16

Cleared

0

Denied

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

14 devices

1-14 of 14

Cleared Nov 27, 1984

SGPT REAGENT SET

Chemistry · 22d

Cleared Nov 27, 1984

SGOT REAGENT SET

Chemistry · 20d

Cleared Nov 20, 1984

ALKALINE PHOSPHATASE REAGENT SET

Chemistry · 19d

Cleared Nov 13, 1984

UREA NITROGEN REAGENT SET

Chemistry · 20d

Cleared Nov 09, 1984

INORGANIC PHOSPHORUS REAGENT SET

Chemistry · 14d

Cleared Nov 02, 1984

HDL PRECIPATATING REAGENT SET

Chemistry · 30d

Cleared Oct 30, 1984

MAGNESIUM REAGENT SET

Chemistry · 27d

Cleared Oct 30, 1984

TOTAL CALCIUM REAGENT SET

Chemistry · 27d

Cleared Oct 30, 1984

CREATININE REAGENT SET

Chemistry · 15d

Cleared Oct 30, 1984

URIC ACID REAGENT SET

Chemistry · 11d

Cleared Oct 11, 1984

ALBUMIN REAGENT SET

Chemistry · 10d

Cleared Oct 01, 1984

TOTAL PROTEIN REAGENT SET

Chemistry · 10d

Cleared Sep 28, 1984

ENZYMATIC CHOLESTEROL KIT

Chemistry · 43d

Cleared Sep 28, 1984

GLUCOSE OXIDASE ENZYMATIC REAGENT SET

Chemistry · 21d