Unipath , Ltd.: FDA filings under this applicant name
FDA lists 73 510(k) clearances under the applicant name “Unipath , Ltd.” (first 1986, latest 2006), across 31 product codes in 5 review panels. Median 510(k) review time under this name: 65 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 20 | 20 |
| JTN | Susceptibility Test Discs, Antimicrobial | 10 | 10 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 | 5 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 | 4 |
| DCF | Albumin, Antigen, Antiserum, Control | 2 | 2 |
| GKZ | Counter, Differential Cell | 2 | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| KTN | System, Test, Infectious Mononucleosis | 2 | 2 |
| MSJ | Apolipoproteins | 2 | 2 |
Plus 21 more product codes.
Review panels
- Clinical Chemistry (34)
- Microbiology (18)
- Immunology (12)
- Hematology (6)
- Clinical Toxicology (3)
Most recent Unipath , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061769 | E.P.T. CERTAINTY 1-STEP PREGNANCY TEST | LCX | 2006-07-03 | 10 |
| K060128 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | LCX | 2006-05-25 | 127 |
| K051638 | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC | GTY | 2005-12-06 | 169 |
| K050930 | E.P.T. CERTAINTY PREGNANCY TEST | LCX | 2005-05-12 | 28 |
| K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT | LCX | 2004-09-10 | 18 |
| K041404 | CLEARBLUE EASY EASY READ PREGNANCY TEST | LCX | 2004-06-08 | 13 |
| K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST | LCX | 2004-03-08 | 25 |
| K040329 | MODIFICATION TO E.P.T. PREGNANCY TEST | LCX | 2004-03-08 | 26 |
| K033658 | E.P.T. PREGNANCY TEST | LCX | 2004-01-16 | 56 |
| K032939 | EPT CERTAINTY PREGNANCY TEST | LCX | 2003-10-20 | 28 |
63 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Unipath , 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Unipath , Ltd. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Unipath , Ltd.?
FDA lists 73 510(k) clearances under the applicant name “Unipath , Ltd.” (first 1986, latest 2006), across 31 product codes in 5 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 Unipath , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unipath , Ltd. is 65 days.
Which FDA product codes appear under Unipath , Ltd.?
The most frequent FDA product codes under this applicant name are LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 20); JTN (Susceptibility Test Discs, Antimicrobial, 10); JHI (Visual, Pregnancy Hcg, Prescription Use, 5).
Next steps
- See all 73 Unipath , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LCX, Unipath , 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.