Quest Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Quest Diagnostics, Inc.” (first 2003, latest 2016), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 240 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 | 1 | 469 |
| 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 | 3 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Quest Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine) | DIO | 2016-11-18 | 469 |
| K080381 | QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA | LAF | 2008-06-25 | 133 |
| K062929 | QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA | DIO | 2006-12-18 | 81 |
| K051161 | QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) | DKZ | 2005-11-22 | 201 |
| K042726 | QUEST DIAGNOSTICS HAIRCHECK-DT (PCP | LCM | 2005-07-28 | 300 |
| K042725 | QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) | DJG | 2005-07-06 | 278 |
| K040257 | QUEST DIAGNOSTICS HAIRCHECK-DT (THC) | LDJ | 2004-06-14 | 131 |
| K023626 | AML HAIRCHECK-DT (COCAINE) | DIO | 2003-09-29 | 335 |
Recalls
openFDA lists no recalls under a recalling firm named Quest Diagnostics, 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.
SEC filings
QUEST DIAGNOSTICS INC (DGX): EDGAR filings, CIK 1022079. An SEC registrant with the same name, matched by name only.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Quest Diagnostics, Inc. (7)
- Quest Diagnostics Incorporated (1)
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 Intl., Inc. (25 510(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 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 Diagnostics, Inc.?
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Quest Diagnostics, Inc.” (first 2003, latest 2016), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Quest Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quest Diagnostics, Inc. is 240 days.
Which FDA product codes appear under Quest Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 3); DJG (Enzyme Immunoassay, Opiates, 1); DKZ (Enzyme Immunoassay, Amphetamine, 1).
Next steps
- See all 8 Quest Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Quest Diagnostics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.