Technia Diagnostics , Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Technia Diagnostics , Ltd.” (first 1979, latest 1986), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | 1 | 1 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| JMF | Radioimmunoassay, Human Placental Lactogen | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 | 1 |
| LCQ | Fluorescent Immunoassay Gentamicin | 1 | 1 |
| LCS | Radioimmunoassay, Digoxin (125-I) | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Clinical Toxicology (2)
- Immunology (1)
Most recent Technia Diagnostics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861978 | AUTOFLUOR V | KTL | 1986-06-10 | 20 |
| K801843 | T3(125) RADIOIMMUNOASSAY KIT | CDP | 1980-09-16 | 46 |
| K801202 | DIGOXIN RADIOIMMUNOASSAY KIT | LCS | 1980-06-20 | 32 |
| K801203 | CORTISOL RADIOIMMUNOASSAY KIT | CGR | 1980-06-09 | 21 |
| K791361 | T3 UPTAKE RADIOIMMUNOASSAY KIT | KHQ | 1979-08-16 | 27 |
| K790919 | HPL RIA KIT | JMF | 1979-06-28 | 45 |
| K790495 | THYROXINE RIA KIT | CDX | 1979-05-03 | 51 |
| K782024 | RIA KIT, VITAMIN B12 | CDD | 1979-02-28 | 85 |
| K782025 | GENTAMICIN FLUROIMMUNASSAY KIT | LCQ | 1979-01-26 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Technia 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 Technia Diagnostics , Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Technia Diagnostics , Ltd.” (first 1979, latest 1986), across 9 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 Technia Diagnostics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Technia Diagnostics , Ltd. is 45 days.
Which FDA product codes appear under Technia Diagnostics , Ltd.?
The most frequent FDA product codes under this applicant name are CDD (Radioassay, Vitamin B12, 1); CDP (Radioimmunoassay, Total Triiodothyronine, 1); CDX (Radioimmunoassay, Total Thyroxine, 1).
Next steps
- See all 9 Technia Diagnostics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CDD, Technia 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.