Alexon, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Alexon, Inc.” (first 1991, latest 1994), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| MHI | Giardia Spp. | 8 | 8 |
| LLH | Reagents, Clostridium Difficile Toxin | 1 | 1 |
| MHJ | Cryptosporidium Spp. | 1 | 1 |
Review panels
- Microbiology (10)
Most recent Alexon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934493 | PROSPECT MICROPLATE ASSAY | LLH | 1994-09-20 | 370 |
| K942098 | PROSPECT GIARDIA | MHI | 1994-09-09 | 148 |
| K931147 | PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION | MHI | 1993-05-13 | 69 |
| K930451 | PROSPEC T GIARDIA MICROTITER ASSAY | MHI | 1993-04-21 | 84 |
| K922675 | PROSPECT GIARDIA CONTROLS | MHI | 1992-09-11 | 99 |
| K922010 | PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION | MHI | 1992-06-19 | 50 |
| K920817 | MODIFICATION PROSPECT GIARDIA RAPID ASSAY | MHI | 1992-04-22 | 76 |
| K912242 | PROSPECT(TM/CRYPTOSPORIDIUM | MHJ | 1992-03-23 | 307 |
| K915093 | PROSPECT(TM) GIARDIA RAPID ASSAY | MHI | 1992-01-30 | 79 |
| K911337 | PROSPEC T/GIARDIA RAPID ASSAY | MHI | 1991-09-27 | 185 |
Recalls
openFDA lists no recalls under a recalling firm named Alexon, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alexon Biomedical, Inc. (5 510(k)s)
- Alexon - Trend, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alexon, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Alexon, Inc.” (first 1991, latest 1994), across 3 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 Alexon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alexon, Inc. is 92 days.
Which FDA product codes appear under Alexon, Inc.?
The most frequent FDA product codes under this applicant name are MHI (Giardia Spp., 8); LLH (Reagents, Clostridium Difficile Toxin, 1); MHJ (Cryptosporidium Spp., 1).
Next steps
- See all 10 Alexon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MHI, Alexon, Inc.'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.