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. Pathology ✕

9 devices

1-9 of 9

Cleared Feb 24, 1989

WRIGHT-GLEMSA STAIN

Pathology · 15d

Cleared Feb 24, 1989

ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET

Pathology · 15d

Cleared Feb 09, 1988

RETICULOCYTE STAIN

Pathology · 42d

Cleared Apr 29, 1987

METHYL GREEN SOLUTION

Pathology · 15d

Cleared Apr 29, 1987

NEW FUCHSIN SOLUTION

Pathology · 15d

Cleared Dec 22, 1986

TISSUE GRAM STAIN

Pathology · 35d

Cleared Nov 13, 1986

RAPID ACID FAST STAIN

Pathology · 29d

Cleared Oct 29, 1986

Pathology · 9d

Cleared Oct 22, 1985

Pathology · 32d