Medical Device Manufacturer · US , Knoxville , TN

Lipogen, Inc.

15 submissions · 15 cleared · Since 1987
15
Total
15
Cleared
0
Denied

Lipogen, Inc. — FDA 510(k) Submissions

Lipogen, Inc. has submitted 15 FDA 510(k) premarket notifications since 1987, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antinuclear Antibody (enzyme-labeled), Antigen, Controls, Anti-rnp Antibody, Antigen And Control, Anti-sm Antibody, Antigen And Control, Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, Punch, Surgical . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
LIPOGEN RHEUMELISA DSDNA ASSAY
K902636 · LRY Punch, Surgical · Immunology
Jun 1990 14d
RHEUMELISA ASSAY FOR SM AUTOANTIBODIES
K895996 · LKP Anti-sm Antibody, Antigen... · Immunology
Nov 1989 24d
RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES
K895997 · LKO Anti-rnp Antibody,... · Immunology
Nov 1989 24d
RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES
K895995 · LJM Antinuclear Antibody... · Immunology
Oct 1989 14d
RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES
K895994 · LJM Antinuclear Antibody... · Immunology
Oct 1989 11d
ANA ANTISERA CONTROL KIT
K894659 · DHN Antinuclear Antibody,... · Immunology
Sep 1989 59d
MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
K892421 · LJM Antinuclear Antibody... · Immunology
May 1989 29d
ACCESS R-CLONE ANA PROFILE ASSAY
K885048 · DHC System, Test, Systemic... · Immunology
Jan 1989 48d
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
K882740 · LKJ Antinuclear Antibody,... · Immunology
Sep 1988 83d
SM ANTIBODY TEST KIT
K880254 · LKP Anti-sm Antibody, Antigen... · Immunology
Apr 1988 77d
RNP ANTIBODY TEST KIT
K874152 · LKO Anti-rnp Antibody,... · Immunology
Mar 1988 150d
LA ANTIBODY TEST KIT
K874195 · LJM Antinuclear Antibody... · Immunology
Mar 1988 149d
LIPOGEN ANA TEST KIT
K875246 · LJM Antinuclear Antibody... · Immunology
Feb 1988 50d
RF DIPSTICK TEST KIT
K874151 · DHR System, Test, Rheumatoid... · Immunology
Dec 1987 77d
NDNA ANTIBODY TEST KIT
K874191 · LRM Anti-dna Antibody... · Immunology
Dec 1987 65d
Filters
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