Lxn Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Lxn Corp.” (first 1996, latest 2001), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 133 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 5 | 5 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Hematology (1)
Most recent Lxn Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002688 | PERSONAL GLUCOSE CONTROL CHARTING SYSTEM | CGA | 2001-02-01 | 156 |
| K991754 | GO GLUCOSE MONITORING SYSTEM | CGA | 1999-09-08 | 107 |
| K990942 | DUET II GLUCOSE CONTROL MONITORING SYSTEM | CGA | 1999-08-02 | 133 |
| K973140 | DUET GLUCOSE CONTROL MONITORING SYSTEM | CGA | 1997-10-31 | 71 |
| K962597 | LXN FRUCTOSAMINE TEST SYSTEM | LCP | 1997-06-13 | 346 |
| K960034 | LXN BLOOD GLUCOSE TEST SYSTEM | CGA | 1996-06-28 | 177 |
| K955629 | LXN FRUCTOSAMINE TEST | JJX | 1996-03-20 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Lxn Corp..
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 Lxn Corp.?
FDA lists 7 510(k) clearances under the applicant name “Lxn Corp.” (first 1996, latest 2001), 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 Lxn Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lxn Corp. is 133 days.
Which FDA product codes appear under Lxn Corp.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 5); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 1); LCP (Assay, Glycosylated Hemoglobin, 1).
Next steps
- See all 7 Lxn Corp. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Lxn Corp.'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.