Medical Device Manufacturer · US , Mchenry , IL

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

30 submissions · 26 cleared · Since 1981

30

Total

26

Cleared

4

Denied

30 devices

26-30 of 30

Not Cleared Feb 03, 2006

INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET

DEN060008 · NXD

Microbiology · 7d

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