Medical Device Manufacturer · US , Mchenry , IL

Centers For Disease Control and Prevention - FDA 510(k) Cleared Devic...

29 submissions · 25 cleared · Since 1981

29

Total

25

Cleared

4

Denied

29 devices

26-29 of 29

Cleared Feb 23, 2000

SYNTHETIC VDRL ANTIGEN

Microbiology · 119d

Cleared Oct 26, 1982

SERA FOR ANTINUCLEAR ANTIBODIES

Microbiology · 203d

Cleared Sep 08, 1981

LEGIONELLA DIRECT FLUORESCENT ANTIBODY

Microbiology · 54d

Cleared Sep 08, 1981

LEGIONELLA INDIRECT FLUOR. ANTIBODY

Microbiology · 54d