Bio Mega Diagnostic, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Bio Mega Diagnostic, Inc.” (first 1976, latest 1987), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 4 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Review panels
- Cardiovascular (4)
- Clinical Chemistry (1)
Most recent Bio Mega Diagnostic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864659 | BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH | JLW | 1987-02-04 | 68 |
| K822438 | BIOMEGA MODEL 59W | DXN | 1982-09-21 | 39 |
| K813556 | MOD. 587 BLOOD PRESSURE & PULSE MONITOR | DXN | 1982-01-22 | 31 |
| K801923 | BIOMEGA #423-B BLOOD PRESSURE & PULSE CK | DXN | 1980-08-27 | 15 |
| K760930 | BLOOD PRESSURE & PULSE CHECKER | DXN | 1976-11-09 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Bio Mega Diagnostic, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio Mega Diagnostic, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Bio Mega Diagnostic, Inc.” (first 1976, latest 1987), across 2 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 Bio Mega Diagnostic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio Mega Diagnostic, Inc. is 31 days.
Which FDA product codes appear under Bio Mega Diagnostic, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 4); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 1).
Next steps
- See all 5 Bio Mega Diagnostic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Bio Mega Diagnostic, 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.