Medical Device Manufacturer · US , UT

Gull Laboratories, Inc.

57 submissions · 57 cleared · Since 1977
57
Total
57
Cleared
0
Denied

Gull Laboratories, Inc. — FDA 510(k) Submissions

Gull Laboratories, Inc. has submitted 57 FDA 510(k) premarket notifications since 1977, of which 57 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific, Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, Enzyme Linked Immunoabsorbent Assay, Rubella, Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, Epstein-barr Virus, Other . Use the specialty filter in the sidebar to narrow results.

57 devices
1–25 of 57
HSV 1+2 IGG ELISA TEST
K983541 · LGC Enzyme Linked... · Microbiology
Feb 1999 140d
MUMPS IGG ELISA TESTY
K971857 · LJY Enzyme Linked... · Microbiology
Nov 1997 168d
TOXO IGG ELISA TEST
K962343 · LGD Enzyme Linked... · Microbiology
Mar 1997 279d
EBNA IGG ELISA TEST
K935730 · LLM Test, Antigen, Nuclear,... · Microbiology
Sep 1995 657d
EBV-EA(D) IGG ELISA TEST
K940093 · LSE Epstein-barr Virus, Other · Microbiology
Sep 1995 616d
VZV IGG ELISA TEST
K941046 · LFY Enzyme Linked... · Microbiology
Aug 1995 535d
EBV LGG ELISA TEST
K941198 · LSE Epstein-barr Virus, Other · Microbiology
Aug 1995 527d
PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR
K932333 · EFB Handpiece, Air-powered,... · Dental
Aug 1995 824d
RUBELLA IGG ELISA TEST
K941624 · LFX Enzyme Linked... · Microbiology
Aug 1995 487d
HSV-1 IGM ELISA TEST -- MODIFICATION
K922758 · LGC Enzyme Linked... · Microbiology
Oct 1992 119d
HSV-2 IGM ELISA TEST--MODIFICATION
K922759 · LGC Enzyme Linked... · Microbiology
Oct 1992 119d
CHAGAS' IGG ELISA TEST
K911233 · MIU Enzyme Linked... · Microbiology
May 1992 411d
TOXO IGG ELISA TEST (MODIFIED)
K915891 · LGD Enzyme Linked... · Microbiology
Mar 1992 71d
RUBELLA IGG ELISA TEST
K915893 · LFX Enzyme Linked... · Microbiology
Mar 1992 71d
CMV IGG ELISA TEST
K915892 · LFZ Enzyme Linked... · Microbiology
Feb 1992 52d
INFLUENZA MAB TEST/INFLUENZA A TEST
K913351 · GNW Antisera, Cf, Influenza... · Microbiology
Dec 1991 144d
INFLUENZA MAB TEST/INFLUENZA B TEST
K913214 · GNW Antisera, Cf, Influenza... · Microbiology
Dec 1991 147d
RSV-MAB TEST
K912842 · LKT Respiratory Syncytial... · Microbiology
Dec 1991 166d
CMV-EA MAB TEST
K912592 · LIN Antisera, Conjugated... · Microbiology
Dec 1991 177d
GULL ELISAWARE
K912558 · LIB Device, General Purpose,... · Microbiology
Sep 1991 97d
VZV IGM TEST
K911301 · GQX Antiserum, Cf,... · Microbiology
Jul 1991 114d
LYME IGM ELISA TEST
K903013 · LSR Reagent, Borrelia... · Microbiology
Jun 1991 345d
HSV-2 IGG ELISA TEST
K910952 · LGC Enzyme Linked... · Microbiology
May 1991 82d
HSV-2 IGM ELISA TEST
K910953 · LGC Enzyme Linked... · Microbiology
May 1991 82d
HSV-1 IGG ELISA TEST
K910954 · LGC Enzyme Linked... · Microbiology
May 1991 83d
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