Murex Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Murex Corp.” (first 1986, latest 1986), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 | 1 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 1 | 1 |
Review panels
- Microbiology (3)
- Clinical Chemistry (1)
- Cardiovascular (1)
Most recent Murex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862048 | SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM | DQX | 1986-06-19 | 21 |
| K861458 | MUREX SUDS TOXO | LGD | 1986-06-13 | 56 |
| K861282 | MUREX SUDS RUBELLA | LFX | 1986-06-13 | 67 |
| K860451 | MUREX (TM), SUDS (TM), HCG ASSAY | LCX | 1986-04-21 | 75 |
| K860576 | MUREX SUDS GROUP A STREP | GTZ | 1986-04-04 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Murex Corp..
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.
- Murex Diagnostics, Inc. (2 510(k)s)
- Murex Biotech , Ltd. (1 510(k)s)
- Murex Diagnostics Limitd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Murex Corp.?
FDA lists 5 510(k) clearances under the applicant name “Murex Corp.” (first 1986, latest 1986), across 5 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 Murex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Murex Corp. is 56 days.
Which FDA product codes appear under Murex Corp.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 1); GTZ (Antisera, All Groups, Streptococcus Spp., 1); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 1).
Next steps
- See all 5 Murex Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Murex Corp.'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.