ARUP Laboratories: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “ARUP Laboratories”, 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 |
|---|---|---|---|
| P190033 | PMA | AAV5 DetectCDx | 2023-06-29 |
Recalls
openFDA lists no recalls under a recalling firm named ARUP Laboratories.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under ARUP Laboratories?
FDA lists 0 510(k) clearances under the applicant name “ARUP Laboratories”, 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 ARUP Laboratories?
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 ARUP Laboratories clearances with predicates and recalls
- Run predicate analysis for product code QWQ, ARUP Laboratories'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.