Lipogen, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Lipogen, Inc. - FDA 510(k) Cleared Devices
15
Total
15
Cleared
0
Denied
Lipogen, Inc. has 15 FDA 510(k) cleared immunology devices. Based in Knoxville, US.
Historical record: 15 cleared submissions from 1987 to 1990.
Browse the complete list of FDA 510(k) cleared immunology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Lipogen, Inc.
15 devices
Cleared
Jun 28, 1990
LIPOGEN RHEUMELISA DSDNA ASSAY
Immunology
14d
Cleared
Nov 06, 1989
RHEUMELISA ASSAY FOR SM AUTOANTIBODIES
Immunology
24d
Cleared
Nov 06, 1989
RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES
Immunology
24d
Cleared
Oct 27, 1989
RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES
Immunology
14d
Cleared
Oct 24, 1989
RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES
Immunology
11d
Cleared
Sep 21, 1989
ANA ANTISERA CONTROL KIT
Immunology
59d
Cleared
May 09, 1989
MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
Immunology
29d
Cleared
Jan 24, 1989
ACCESS R-CLONE ANA PROFILE ASSAY
Immunology
48d
Cleared
Sep 22, 1988
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
Immunology
83d
Cleared
Apr 06, 1988
SM ANTIBODY TEST KIT
Immunology
77d
Cleared
Mar 11, 1988
RNP ANTIBODY TEST KIT
Immunology
150d
Cleared
Mar 11, 1988
LA ANTIBODY TEST KIT
Immunology
149d
Cleared
Feb 10, 1988
LIPOGEN ANA TEST KIT
Immunology
50d
Cleared
Dec 29, 1987
RF DIPSTICK TEST KIT
Immunology
77d
Cleared
Dec 18, 1987
NDNA ANTIBODY TEST KIT
Immunology
65d