Omega Medical Diagnostics: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Omega Medical Diagnostics” (first 1983, latest 1983), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| PPM | General Purpose Reagent | 2 | 2 |
| GGK | Products, Red-Cell Lysing Products | 1 | 1 |
| GIF | Diluent, Blood Cell | 1 | 1 |
| GKR | System, Hemoglobin, Automated | 1 | 1 |
Review panels
- Hematology (3)
- Pathology (2)
Most recent Omega Medical Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832182 | LYSING REAGENT | GGK | 1983-08-12 | 36 |
| K831620 | SODIUM HYPOCHLORITE 3% | PPM | 1983-07-28 | 70 |
| K831619 | SODIUM HYPOCHLORITE 7% | PPM | 1983-07-28 | 70 |
| K831618 | HEMOGLOBIN REAGENT | GKR | 1983-06-16 | 28 |
| K831617 | DILUENT | GIF | 1983-06-16 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Omega Medical Diagnostics.
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.
- Omega Medical Electronics (21 510(k)s)
- Omega Medical Imaging, Inc. (15 510(k)s)
- Omega Laboratories, Inc. (9 510(k)s)
- Omega Silicone, Inc. (5 510(k)s)
- Omega Surgical Instruments, Inc. (3 510(k)s)
- Omega Universal Technologies, Ltd. (3 510(k)s)
- Omega Medical Corp. (2 510(k)s)
- Omega Critical Care Limited (1 510(k)s)
- Omega Group, Inc. (1 510(k)s)
- Omega Hearing Aid Center (1 510(k)s)
- Omega Mark-3 Pen Corp. (1 510(k)s)
- Omega Medical Services, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omega Medical Diagnostics?
FDA lists 5 510(k) clearances under the applicant name “Omega Medical Diagnostics” (first 1983, latest 1983), across 4 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 Omega Medical Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omega Medical Diagnostics is 36 days.
Which FDA product codes appear under Omega Medical Diagnostics?
The most frequent FDA product codes under this applicant name are PPM (General Purpose Reagent, 2); GGK (Products, Red-Cell Lysing Products, 1); GIF (Diluent, Blood Cell, 1).
Next steps
- See all 5 Omega Medical Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code PPM, Omega Medical Diagnostics'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.