M.A. Bioproducts: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “M.A. Bioproducts” (first 1980, latest 1983), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 67 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 |
|---|---|---|---|
| GOL | Antigen, Ha (Including Ha Control), Rubella | 1 | 1 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 1 | 1 |
| LCS | Radioimmunoassay, Digoxin (125-I) | 1 | 1 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 1 | 1 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 1 | 1 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 1 | 1 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 1 | 1 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 1 |
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | 1 |
Plus 2 more product codes.
Review panels
- Microbiology (9)
- Pathology (1)
- Clinical Toxicology (1)
Most recent M.A. Bioproducts 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K822883 | HERPELISA KIT | LGC | 1983-07-26 | 306 |
| K823804 | MYCOPLASMELISA TEST KIT | LJZ | 1983-05-25 | 159 |
| K830045 | MUMPSELISA TEST KIT | LJY | 1983-05-13 | 123 |
| K830615 | CYTOMEGELISA STAT | LFZ | 1983-05-09 | 70 |
| K823805 | VARICELISA TEST KIT | LFY | 1983-05-05 | 139 |
| K821967 | CHLAMYDELISA TEST KIT | LJC | 1982-08-03 | 32 |
| K821762 | MEASELISA TEST KIT | LJB | 1982-07-30 | 45 |
| K813221 | TOXOELISA TEST KIT | LGD | 1982-01-26 | 78 |
| K812531 | CELL CULTURE REAGENTS | KIT | 1981-10-23 | 51 |
| K812123 | CYTOMEGELISA TEST KIT | — | 1981-09-23 | 58 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named M.A. Bioproducts.
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 M.A. Bioproducts?
FDA lists 12 510(k) clearances under the applicant name “M.A. Bioproducts” (first 1980, latest 1983), across 12 product codes in 3 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 M.A. Bioproducts?
The median time from FDA receipt to decision across 510(k)s cleared under the name M.A. Bioproducts is 67 days.
Which FDA product codes appear under M.A. Bioproducts?
The most frequent FDA product codes under this applicant name are GOL (Antigen, Ha (Including Ha Control), Rubella, 1); KIT (Media And Components, Synthetic Cell And Tissue Culture, 1); LCS (Radioimmunoassay, Digoxin (125-I), 1).
Next steps
- See all 12 M.A. Bioproducts clearances with predicates and recalls
- Run predicate analysis for product code GOL, M.A. Bioproducts'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.