Medical Device Manufacturer · US , UT

Gull Laboratories, Inc. - FDA 510(k) Cleared Devices

57 submissions · 57 cleared · Since 1977

57

Total

57

Cleared

0

Denied

57 devices

26-50 of 57

Cleared May 28, 1991

HSV-1 IGM ELISA TEST

Microbiology · 83d

Cleared Apr 12, 1991

EBV IGG ELISA TEST

Microbiology · 42d

Cleared Feb 21, 1991

EBV IGM ELISA TEST

Microbiology · 48d

Cleared Jan 03, 1991

RUBEOLA IGM ELISA TEST

Microbiology · 120d

Cleared Dec 17, 1990

CMV IGM ELISA TEST

Microbiology · 119d

Cleared Dec 04, 1990

RUBELLA IGM ELISA TEST

Microbiology · 90d

Cleared Dec 04, 1990

RUBEOLA IGG ELISA TEST

Microbiology · 36d

Cleared Oct 16, 1990

TOXO IGM ELISA TEST

Microbiology · 83d

Cleared Jun 28, 1990

RUBELLA IGG ELISA TEST

Microbiology · 80d

Cleared May 02, 1990

CMV IGG ELISA TEST

Microbiology · 71d

Cleared Apr 16, 1990

TOXO IGG ELISA TEST

Microbiology · 81d

Cleared Dec 18, 1989

DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST

Microbiology · 236d

Cleared Dec 18, 1989

DETECTADOT TM SYSTEM 2000 CMV IGM TEST

Microbiology · 234d

Cleared Oct 31, 1989

DETECTADOT SYSTEM 2000 HETEROPHILE TEST

Immunology · 26d

Cleared Sep 13, 1989

DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST

Microbiology · 163d

Cleared Dec 05, 1988

Microbiology · 75d

Cleared Aug 30, 1988

ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST

Microbiology · 61d

Cleared May 06, 1988

DETECTADOT SYSTEM 2000 CMV IGG TEST

Microbiology · 142d

Cleared Mar 31, 1988

Microbiology · 91d

Cleared Mar 24, 1988

Microbiology · 78d

Cleared Mar 17, 1988

Microbiology · 73d

Cleared Mar 07, 1988

DETECTADOT SYSTEM 2000 TOXO IGG TEST

Microbiology · 84d

Cleared Feb 17, 1988

GULLSORB IGG INACTIVATION REAGENT

Immunology · 57d

Cleared Jan 05, 1988

Microbiology · 183d

Cleared Nov 14, 1985

Microbiology · 111d