Medical Device Manufacturer · US , Washington , DC

Orgenics, Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1989

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orgenics, Ltd. Microbiology ✕

3 devices

1-3 of 3

Cleared Mar 13, 1990

ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG

Microbiology · 183d

Cleared Jun 23, 1989

ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT

Microbiology · 101d

Cleared Apr 12, 1989

IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT

Microbiology · 105d