Alexon Biomedical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Alexon Biomedical, Inc.” (first 1988, latest 1997), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 1 | 1 |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 1 | 1 |
| LLH | Reagents, Clostridium Difficile Toxin | 1 | 1 |
| MHI | Giardia Spp. | 1 | 1 |
| MHJ | Cryptosporidium Spp. | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Alexon Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964864 | PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY | LLH | 1997-02-04 | 62 |
| K955157 | PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY | MHI | 1996-02-09 | 88 |
| K936191 | PROSPECT CRYPTOSPORIDIUM RAPID ASSAY | MHJ | 1994-11-17 | 329 |
| K933997 | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY | GMD | 1993-11-22 | 97 |
| K874849 | PROSPECT/GIARDIA | KHW | 1988-01-05 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Alexon Biomedical, 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, Inc. (10 510(k)s)
- Alexon - Trend, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alexon Biomedical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Alexon Biomedical, Inc.” (first 1988, latest 1997), across 5 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 Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alexon Biomedical, Inc. is 88 days.
Which FDA product codes appear under Alexon Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans, 1); KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp., 1); LLH (Reagents, Clostridium Difficile Toxin, 1).
Next steps
- See all 5 Alexon Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GMD, Alexon Biomedical, 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, 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.