Medical Device Manufacturer · US , Mchenry , IL

Diagnostic Specialties - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1981

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diagnostic Specialties Chemistry ✕

6 devices

1-6 of 6

Cleared Sep 02, 1997

ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT

Chemistry · 133d

Cleared Jul 30, 1992

ENZIP URINARY MICROALBUMIN TEST

Chemistry · 90d

Cleared May 27, 1983

PREGNA-CERT, SLIDE PREGNANCY TEST

Chemistry · 46d

Cleared Nov 10, 1982

GENERIC PREGNANCY TEST

Chemistry · 20d

Cleared Jan 22, 1982

POTASSIUM REAGENT SET

Chemistry · 24d

Cleared Dec 31, 1981

GLUCOSE ENZYME-COLOR REAGENT SET

Chemistry · 27d