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

FDA 510(k) Regulatory Record - Gull Laboratories, Inc. Microbiology ✕

51 devices

1-12 of 51

Cleared Feb 26, 1999

HSV 1+2 IGG ELISA TEST

Microbiology · 140d

Cleared Nov 04, 1997

MUMPS IGG ELISA TESTY

Microbiology · 168d

Cleared Mar 24, 1997

TOXO IGG ELISA TEST

Microbiology · 279d

Cleared Sep 19, 1995

EBNA IGG ELISA TEST

Microbiology · 657d

Cleared Sep 15, 1995

EBV-EA(D) IGG ELISA TEST

Microbiology · 616d

Cleared Aug 24, 1995

VZV IGG ELISA TEST

Microbiology · 535d

Cleared Aug 23, 1995

EBV LGG ELISA TEST

Microbiology · 527d

Cleared Aug 04, 1995

RUBELLA IGG ELISA TEST

Microbiology · 487d

Cleared Oct 05, 1992

HSV-1 IGM ELISA TEST -- MODIFICATION

Microbiology · 119d

Cleared Oct 05, 1992

HSV-2 IGM ELISA TEST--MODIFICATION

Microbiology · 119d

Cleared May 04, 1992

CHAGAS' IGG ELISA TEST

Microbiology · 411d

Cleared Mar 04, 1992

TOXO IGG ELISA TEST (MODIFIED)

Microbiology · 71d

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