Medical Device Manufacturer · US , Mchenry , IL

American Micro Scan

24 submissions · 24 cleared · Since 1983
24
Total
24
Cleared
0
Denied

American Micro Scan — FDA 510(k) Submissions

American Micro Scan has submitted 24 FDA 510(k) premarket notifications since 1983, of which 24 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Manual Antimicrobial Susceptibility Test Systems, Antiserum, Fluorescent, Chlamydia Trachomatis, Discs, Strips And Reagents, Microorganism Differentiation, Colorimeter, Photometer, Spectrophotometer For Clinical Use, Culture Media, Multiple Biochemical Test . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
K864662 · LJP Antiserum, Fluorescent,... · Microbiology
Mar 1987 117d
IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
K870029 · GWC Antisera, All Types,... · Microbiology
Mar 1987 79d
MICRODILUTION MIC PANELS
K863776 · JWY Manual Antimicrobial... · Microbiology
Feb 1987 130d
MICRODILUTION IDENTIFICATION PANELS
K864674 · JSE Culture Media, Multiple... · Microbiology
Jan 1987 34d
CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
K864389 · LJP Antiserum, Fluorescent,... · Microbiology
Dec 1986 28d
GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
K863038 · LQL Gram Positive... · Microbiology
Sep 1986 49d
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
K862642 · LQM Gram Negative... · Microbiology
Sep 1986 62d
ANAEROBE RAPID CHROMOGENIC ID PANEL
K862332 · JSP Kit, Anaerobic... · Microbiology
Aug 1986 69d
MICRODILUTION PANELS
K862140 · JWY Manual Antimicrobial... · Microbiology
Jul 1986 42d
GRAM NEGATIVE COMBO PANEL TYPE 3
K861584 · JWY Manual Antimicrobial... · Microbiology
Jun 1986 49d
YEAST IDENTIFICATION PANEL
K860575 · JXB Kit, Identification, Yeast · Microbiology
May 1986 84d
NEG COMBO BREAKPOINT PANEL POS COMBO
K854278 · JWX Kit, Screening,... · Microbiology
Mar 1986 131d
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
K854447 · GTZ Antisera, All Groups,... · Microbiology
Jan 1986 59d
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
K854490 · GRP Antisera, All Types, H.... · Microbiology
Dec 1985 45d
NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC
K852976 · Microbiology
Dec 1985 142d
AUTOSCAN W/A SYSTEM
K854448 · JTO Discs, Strips And... · Microbiology
Nov 1985 21d
POS COMBO PANEL
K844086 · JTO Discs, Strips And... · Microbiology
Nov 1984 22d
MICROBIOLOGICAL TRAY READER-MANUAL
K842947 · JJQ Colorimeter, Photometer,... · Microbiology
Sep 1984 50d
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
K842874 · JTA Monitor, Microbial Growth · Microbiology
Sep 1984 51d
HAEMOPHILUS/NEISSERIA IDENTIF-PANEL
K833027 · Microbiology
Oct 1983 51d
SAF FIXATIVE
K831058 · LDW Fixative, Acid Containing · Pathology
Jun 1983 68d
TRICHROME STAIN
K831060 · JTS Stains, Microbiologic · Pathology
Jun 1983 68d
PVA FIXATIVE/FORMALIN
K831061 · LDZ Fixative, Alcohol Containing · Pathology
Jun 1983 68d
P & T MEDIUM
K831059 · JSM Culture Media,... · Pathology
Apr 1983 27d
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