Biomedical Diagnostics (Bmd) SA: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biomedical Diagnostics (Bmd) SA” (first 2005, latest 2010), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 138 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 3 | 3 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 3 | 3 |
| JZO | System, Test, Thyroid Autoantibody | 1 | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 | 1 |
| LSW | Anti-Dna Antibody, Antigen And Control | 1 | 1 |
| MST | Antibodies, Gliadin | 1 | 1 |
Review panels
- Immunology (10)
Most recent Biomedical Diagnostics (Bmd) SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | LLL | 2010-12-03 | 84 |
| K100917 | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | MOB | 2010-11-03 | 215 |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | MOB | 2007-12-21 | 308 |
| K071210 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | LKO | 2007-12-19 | 232 |
| K061794 | FIDIS TM THYRO, MODEL MX002 | JZO | 2006-11-21 | 148 |
| K060380 | FIDIS DSDNA | LSW | 2006-05-02 | 77 |
| K053383 | FIDIS CELIAC | MST | 2006-03-29 | 114 |
| K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | LLL | 2006-03-13 | 73 |
| K053012 | FIDIS VASCULITIS, MODEL MX007 | MOB | 2006-03-02 | 127 |
| K050286 | FIDIS CONNECTIVE 8 | LLL | 2005-10-03 | 238 |
Recalls
openFDA lists no recalls under a recalling firm named Biomedical Diagnostics (Bmd) SA.
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.
- Biomedical Life Systems, Inc. (37 510(k)s)
- Biomedical Ent., Inc. (13 510(k)s)
- Biomedical Dynamics, Inc. (10 510(k)s)
- Biomedical Enterprises, Inc. (10 510(k)s)
- Biomedical Devices, Inc. (7 510(k)s)
- Biomedical Concepts, Inc. (3 510(k)s)
- Biomedical Design Instruments (3 510(k)s)
- Biomedical Research & Development Laboratories, Inc. (3 510(k)s)
- Biomedical Sensors, Inc. (3 510(k)s)
- Biomedical Systems Corp. (3 510(k)s)
- Biomedical Composites, Ltd. (2 510(k)s)
- Biomedical Exports, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomedical Diagnostics (Bmd) SA?
FDA lists 10 510(k) clearances under the applicant name “Biomedical Diagnostics (Bmd) SA” (first 2005, latest 2010), across 6 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 Biomedical Diagnostics (Bmd) SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomedical Diagnostics (Bmd) SA is 138 days.
Which FDA product codes appear under Biomedical Diagnostics (Bmd) SA?
The most frequent FDA product codes under this applicant name are LLL (Extractable Antinuclear Antibody, Antigen And Control, 3); MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca), 3); JZO (System, Test, Thyroid Autoantibody, 1).
Next steps
- See all 10 Biomedical Diagnostics (Bmd) SA clearances with predicates and recalls
- Run predicate analysis for product code LLL, Biomedical Diagnostics (Bmd) SA'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.