Medical Device Manufacturer · US , Knoxville , TN

Lipogen, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1987

Recent clearances: LIPOGEN RHEUMELISA DSDNA ASSAY, RHEUMELISA ASSAY FOR SM AUTOANTIBODIES, RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

View 15 510(k) Devices ↓

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lipogen, Inc. Immunology ✕

15 devices

1-12 of 15

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