Medical Device Manufacturer · US , Mchenry , IL

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

164 submissions · 164 cleared · Since 1984

164

Total

164

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sigma Diagnostics, Inc. Microbiology ✕

7 devices

1-7 of 7

Cleared Apr 21, 1988

ACID FAST BACILLI HISTOLOGY CONTROL SLIDES

Microbiology · 37d

Cleared Apr 21, 1988

SPIROCHETES HISTOLOGY CONTROL SLIDES

Microbiology · 37d

Cleared Apr 21, 1988

FUNGI HISTOLOGY CONTROL SLIDES

Microbiology · 37d

Cleared Apr 12, 1988

PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES

Microbiology · 28d

Cleared Apr 12, 1988

LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES

Microbiology · 28d

Cleared Mar 30, 1988

INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES

Microbiology · 15d

Cleared Mar 30, 1988

INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL

Microbiology · 15d