American Micro Scan

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K870029IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEMarch 25, 1987
K864662CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARSMarch 25, 1987
K863776MICRODILUTION MIC PANELSFebruary 2, 1987
K864674MICRODILUTION IDENTIFICATION PANELSJanuary 5, 1987
K864389CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TESTDecember 4, 1986
K863038GRAM POSITIVE FLUORESCENT IDENTIFICATION PANELSeptember 30, 1986
K862642GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANELSeptember 11, 1986
K862332ANAEROBE RAPID CHROMOGENIC ID PANELAugust 27, 1986
K862140MICRODILUTION PANELSJuly 16, 1986
K861584GRAM NEGATIVE COMBO PANEL TYPE 3June 17, 1986
K860575YEAST IDENTIFICATION PANELMay 13, 1986
K854278NEG COMBO BREAKPOINT PANEL POS COMBOMarch 4, 1986
K854447IMMUNOSCAN RAPID DIRECT GROUP A STREP TESTJanuary 3, 1986
K854490IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TESDecember 27, 1985
K852976NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MICDecember 4, 1985
K854448AUTOSCAN W/A SYSTEMNovember 26, 1985
K844086POS COMBO PANELNovember 13, 1984
K842947MICROBIOLOGICAL TRAY READER-MANUALSeptember 14, 1984
K842874RADIOMETRIC BLOOD CULTURE VIALS, AEROBESeptember 12, 1984
K833027HAEMOPHILUS/NEISSERIA IDENTIF-PANELOctober 28, 1983