Medical Device Manufacturer · US , Des Plaines , IL

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

15 submissions · 15 cleared · Since 2000

15

Total

15

Cleared

0

Denied

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

15 devices

1-12 of 15

Cleared Apr 02, 2004

MESACUP TEST PR-3

Immunology · 15d

Cleared Mar 22, 2004

MESACUP TEST MPO, MODEL 11053

Immunology · 17d

Cleared Mar 04, 2004

MESACUP-2 TEST CENP-B

Immunology · 35d

Cleared Dec 22, 2003

MESACUP-2 TEST JO-1, MODEL 10756

Immunology · 45d

Cleared Sep 26, 2003

RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760

Immunology · 155d

Cleared Aug 14, 2002

RHIGENE MESACUP-2 TEST RNP, MODEL M7741

Immunology · 55d

Cleared Jul 05, 2002

RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560

Immunology · 15d

Cleared Apr 11, 2002

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L

Immunology · 367d

Cleared Jun 09, 2000

RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E

Immunology · 127d

Cleared May 09, 2000

RHIGENE MESACUP2 TEST- SSA

Immunology · 62d

Cleared May 09, 2000

RHIGENE MESACUP2 TEST- SCL-70

Immunology · 62d

Cleared May 09, 2000

RHIGENE MESACUP2 TEST- SSB

Immunology · 62d