Unipath , Ltd.: FDA clearances and approvals
Unipath , Ltd. has 73 FDA 510(k) clearances (first 1986, latest 2006), across 31 product codes in 5 review panels. Median 510(k) review time: 65 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Unipath , Ltd.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Unipath , Ltd. have?
Unipath , Ltd. has 73 FDA 510(k) clearances (first 1986, latest 2006), across 31 product codes in 5 review panels.
How long does FDA take to clear Unipath , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Unipath , Ltd.'s cleared 510(k)s is 65 days.
What devices does Unipath , Ltd. make?
Its most frequent FDA product codes are LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 20); JTN (Susceptibility Test Discs, Antimicrobial, 10); JHI (Visual, Pregnancy Hcg, Prescription Use, 5).
Has Unipath , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Unipath , Ltd. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.