Quest Intl., Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Quest Intl., Inc.” (first 1989, latest 2009), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | 4 | 4 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | 2 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | 2 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 2 | 2 |
| LKP | Anti-Sm Antibody, Antigen And Control | 2 | 2 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 1 | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 | 1 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 1 | 1 |
Plus 6 more product codes.
Review panels
- Microbiology (15)
- Immunology (8)
- General Hospital (2)
Most recent Quest Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091260 | SERAQUEST EBV EA-D IGG TEST | LSE | 2009-06-08 | 40 |
| K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | LSE | 2004-01-16 | 29 |
| K033780 | MODIFICATION TO SERAQUEST VCA IGM | LJN | 2004-01-15 | 42 |
| K023593 | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) | JZO | 2003-02-06 | 104 |
| K023592 | SERAQUEST ANTI-THYROGLOBULIN | DDC | 2003-01-06 | 73 |
| K003069 | ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM | MID | 2000-11-27 | 56 |
| K991975 | SERAQUEST EB NA IGG | LSE | 1999-11-02 | 144 |
| K990410 | SERAQUEST EB VCA IGG | LSE | 1999-10-28 | 261 |
| K990977 | SERAQUEST EB VAC IGM | LJN | 1999-10-06 | 197 |
| K982485 | SERAQUEST CMV IGM | LFZ | 1999-01-13 | 180 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Quest Intl., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Quest Medical, Inc. (39 510(k)s)
- Quest Diagnostics, Inc. (7 510(k)s)
- Quest International, Inc. (3 510(k)s)
- Quest Dental USA Corp. (2 510(k)s)
- Quest Medical Imaging (2 510(k)s)
- Quest Diagnostics Incorporated (1 510(k)s)
- Quest Enabling Designs , Ltd. (1 510(k)s)
- Quest Diagnostics Nichols Institute (0 510(k)s)
- Quest Technologies Corp. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quest Intl., Inc.?
FDA lists 25 510(k) clearances under the applicant name “Quest Intl., Inc.” (first 1989, latest 2009), across 16 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Quest Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quest Intl., Inc. is 108 days.
Which FDA product codes appear under Quest Intl., Inc.?
The most frequent FDA product codes under this applicant name are LSE (Epstein-Barr Virus, Other, 4); LFX (Enzyme Linked Immunoabsorbent Assay, Rubella, 2); LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, 2).
Next steps
- See all 25 Quest Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSE, Quest Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.