American Micro Scan - FDA 510(k) Cleared Devices
24
Total
24
Cleared
0
Denied
20 devices
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
Cleared
Jan 03, 1986
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
Microbiology
59d
Cleared
Dec 27, 1985
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
Microbiology
45d
Cleared
Dec 04, 1985
NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC
Microbiology
142d
Cleared
Nov 26, 1985
AUTOSCAN W/A SYSTEM
Microbiology
21d
Cleared
Nov 13, 1984
POS COMBO PANEL
Microbiology
22d
Cleared
Sep 14, 1984
MICROBIOLOGICAL TRAY READER-MANUAL
Microbiology
50d
Cleared
Sep 12, 1984
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
Microbiology
51d
Cleared
Oct 28, 1983
HAEMOPHILUS/NEISSERIA IDENTIF-PANEL
Microbiology
51d