Cheshire Diagnostics , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cheshire Diagnostics , Ltd.” (first 2002, latest 2002), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 3 | 3 |
| MID | System, Test, Anticardiolipin Immunological | 2 | 2 |
| MVS | Kit, Typing, Hla-Dqb | 1 | 1 |
Review panels
- Immunology (5)
- Hematology (1)
Most recent Cheshire Diagnostics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021611 | QAB2A IGG ELISA KIT HRP | MSV | 2002-07-12 | 57 |
| K021610 | QAB2A IGM ELISA KIT HRP | MSV | 2002-07-12 | 57 |
| K021192 | QACA IGG/IGM ELISA KIT HRP | MID | 2002-05-16 | 31 |
| K020695 | QAB2A IGG ELISA KIT | MSV | 2002-04-19 | 46 |
| K020694 | QAB2A IGM ELISA KIT | MVS | 2002-04-19 | 46 |
| K020241 | QACA IGG/IGM ELISA KIT | MID | 2002-03-13 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Cheshire Diagnostics , Ltd..
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 Cheshire Diagnostics , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Cheshire Diagnostics , Ltd.” (first 2002, latest 2002), across 3 product codes in 2 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 Cheshire Diagnostics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cheshire Diagnostics , Ltd. is 48 days.
Which FDA product codes appear under Cheshire Diagnostics , Ltd.?
The most frequent FDA product codes under this applicant name are MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), 3); MID (System, Test, Anticardiolipin Immunological, 2); MVS (Kit, Typing, Hla-Dqb, 1).
Next steps
- See all 6 Cheshire Diagnostics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MSV, Cheshire Diagnostics , Ltd.'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.