Mercia Diagnostics , Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Mercia Diagnostics , Ltd.” (first 1987, latest 1992), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 121 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 |
|---|---|---|---|
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 4 | 4 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 3 | 3 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 | 3 |
| JWZ | Kit, Screening, Trichomonas | 2 | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | 2 |
| GOB | Antigens, Ha (Including Ha Control), Adenovirus 1-33 | 1 | 1 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 | 1 |
| LRF | Candida Spp., Direct Antigen, Id | 1 | 1 |
Review panels
- Microbiology (17)
Most recent Mercia Diagnostics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915479 | CAPTIA CMV-TA | LFZ | 1992-05-04 | 150 |
| K904524 | CAPTIA(R) SYPHILIS M, MODIFICATION | LIP | 1990-12-26 | 90 |
| K900654 | MODIFIED CAPTIA(R) SYPHILIS-M | LIP | 1990-03-08 | 27 |
| K900655 | MODIFIED CAPTIA(R) TOXO-M | LGD | 1990-03-06 | 25 |
| K896295 | CAPTIA(R) CMV-M | LFZ | 1990-03-06 | 126 |
| K896194 | CAPTIA(R) CMV-G | LFZ | 1990-03-06 | 132 |
| K885300 | CAPTIA(R) RUBELLA-M | LFX | 1989-08-15 | 231 |
| K883924 | CAPTIA(R) RUBELLA-G | LFX | 1989-08-15 | 333 |
| K892802 | SUPER DUO | JWZ | 1989-06-13 | 57 |
| K881425 | CAPTIA(R) SYPHILIS-G | LIP | 1988-08-04 | 121 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mercia 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 Mercia Diagnostics , Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Mercia Diagnostics , Ltd.” (first 1987, latest 1992), across 8 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 Mercia Diagnostics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mercia Diagnostics , Ltd. is 121 days.
Which FDA product codes appear under Mercia Diagnostics , Ltd.?
The most frequent FDA product codes under this applicant name are LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, 4); LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, 3); LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, 3).
Next steps
- See all 17 Mercia Diagnostics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LIP, Mercia 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, 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.