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American Micro Scan

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K864662 CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARSLJP1987-03-25 View
510(k) K870029 IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEGWC1987-03-25 View
510(k) K863776 MICRODILUTION MIC PANELSJWY1987-02-02 View
510(k) K864674 MICRODILUTION IDENTIFICATION PANELSJSE1987-01-05 View
510(k) K864389 CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TESTLJP1986-12-04 View
510(k) K863038 GRAM POSITIVE FLUORESCENT IDENTIFICATION PANELLQL1986-09-30 View
510(k) K862642 GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANELLQM1986-09-11 View
510(k) K862332 ANAEROBE RAPID CHROMOGENIC ID PANELJSP1986-08-27 View
510(k) K862140 MICRODILUTION PANELSJWY1986-07-16 View
510(k) K861584 GRAM NEGATIVE COMBO PANEL TYPE 3JWY1986-06-17 View
510(k) K860575 YEAST IDENTIFICATION PANELJXB1986-05-13 View
510(k) K854278 NEG COMBO BREAKPOINT PANEL POS COMBOJWX1986-03-04 View
510(k) K854447 IMMUNOSCAN RAPID DIRECT GROUP A STREP TESTGTZ1986-01-03 View
510(k) K854490 IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TESGRP1985-12-27 View
510(k) K852976 NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC1985-12-04 View
510(k) K854448 AUTOSCAN W/A SYSTEMJTO1985-11-26 View
510(k) K844086 POS COMBO PANELJTO1984-11-13 View
510(k) K842947 MICROBIOLOGICAL TRAY READER-MANUALJJQ1984-09-14 View
510(k) K842874 RADIOMETRIC BLOOD CULTURE VIALS, AEROBEJTA1984-09-12 View
510(k) K833027 HAEMOPHILUS/NEISSERIA IDENTIF-PANEL1983-10-28 View
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