Medical Device Manufacturer · US , Mchenry , IL

American Micro Scan - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1983

24

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Micro Scan Microbiology ✕

20 devices

1-12 of 20

Cleared Mar 25, 1987

CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS

Microbiology · 117d

Cleared Mar 25, 1987

IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE

Microbiology · 79d

Cleared Feb 02, 1987

MICRODILUTION MIC PANELS

Microbiology · 130d

Cleared Jan 05, 1987

MICRODILUTION IDENTIFICATION PANELS

Microbiology · 34d

Cleared Dec 04, 1986

CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST

Microbiology · 28d

Cleared Sep 30, 1986

GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL

Microbiology · 49d

Cleared Sep 11, 1986

GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL

Microbiology · 62d

Cleared Aug 27, 1986

ANAEROBE RAPID CHROMOGENIC ID PANEL

Microbiology · 69d

Cleared Jul 16, 1986

MICRODILUTION PANELS

Microbiology · 42d

Cleared Jun 17, 1986

GRAM NEGATIVE COMBO PANEL TYPE 3

Microbiology · 49d

Cleared May 13, 1986

YEAST IDENTIFICATION PANEL

Microbiology · 84d

Cleared Mar 04, 1986

NEG COMBO BREAKPOINT PANEL POS COMBO

Microbiology · 131d