Gull Laboratories, Inc.: FDA clearances and approvals
Gull Laboratories, Inc. has 57 FDA 510(k) clearances (first 1977, latest 1999), across 29 product codes in 3 review panels. Median 510(k) review time: 97 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 7 | 7 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 6 | 6 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 5 | 5 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 4 | 4 |
| LSE | Epstein-Barr Virus, Other | 3 | 3 |
| GLZ | Antigens, If, Toxoplasma Gondii | 2 | 2 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 2 | 2 |
| GQI | Antiserum, Cf, Cytomegalovirus | 2 | 2 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 2 | 2 |
| GQX | Antiserum, Cf, Varicella-Zoster | 2 | 2 |
Plus 19 more product codes.
Review panels
- Microbiology (54)
- Immunology (2)
- Dental (1)
Most recent Gull Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983541 | HSV 1+2 IGG ELISA TEST | LGC | 1999-02-26 | 140 |
| K971857 | MUMPS IGG ELISA TESTY | LJY | 1997-11-04 | 168 |
| K962343 | TOXO IGG ELISA TEST | LGD | 1997-03-24 | 279 |
| K935730 | EBNA IGG ELISA TEST | LLM | 1995-09-19 | 657 |
| K940093 | EBV-EA(D) IGG ELISA TEST | LSE | 1995-09-15 | 616 |
| K941046 | VZV IGG ELISA TEST | LFY | 1995-08-24 | 535 |
| K941198 | EBV LGG ELISA TEST | LSE | 1995-08-23 | 527 |
| K932333 | PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR | EFB | 1995-08-15 | 824 |
| K941624 | RUBELLA IGG ELISA TEST | LFX | 1995-08-04 | 487 |
| K922759 | HSV-2 IGM ELISA TEST--MODIFICATION | LGC | 1992-10-05 | 119 |
47 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gull Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Gull Laboratories, Inc.'s product codes (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNW)
- Q2039 — Influenza virus vaccine, not otherwise specified (via GNW)
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu) (via GNW)
Frequently asked questions
How many FDA 510(k) clearances does Gull Laboratories, Inc. have?
Gull Laboratories, Inc. has 57 FDA 510(k) clearances (first 1977, latest 1999), across 29 product codes in 3 review panels.
How long does FDA take to clear Gull Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Gull Laboratories, Inc.'s cleared 510(k)s is 97 days.
What devices does Gull Laboratories, Inc. make?
Its most frequent FDA product codes are LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific, 7); LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, 6); LFX (Enzyme Linked Immunoabsorbent Assay, Rubella, 5).
Has Gull Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Gull Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 57 Gull Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LGC, Gull Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.