Quest Diagnostics Nichols Institute: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Quest Diagnostics Nichols Institute”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QWQ | Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors | 1 | 0 |
Review panels
- Immunology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250002 | PMA | Quest Diagnostics AAVrh74 Antibody ELISA CDx | 2025-07-24 |
Recalls
openFDA lists no recalls under a recalling firm named Quest Diagnostics Nichols Institute.
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 Intl., Inc. (25 510(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 Technologies Corp. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quest Diagnostics Nichols Institute?
FDA lists 0 510(k) clearances under the applicant name “Quest Diagnostics Nichols Institute”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Quest Diagnostics Nichols Institute?
The most frequent FDA product codes under this applicant name are QWQ (Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors, 1).
Next steps
- See all 0 Quest Diagnostics Nichols Institute clearances with predicates and recalls
- Run predicate analysis for product code QWQ, Quest Diagnostics Nichols Institute'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.