Zeus Technologies: FDA clearances and approvals
Zeus Technologies has 4 FDA 510(k) clearances (first 1983, latest 1984), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time: 69 days.
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 |
|---|---|---|---|
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | 2 |
| GRZ | Antisera, Fluorescent, All, Mycoplasma Spp. | 1 | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 1 |
| LPJ | Kit, Assay, Estrogen Receptor | 1 | 0 |
Review panels
- Microbiology (4)
- Clinical Chemistry (1)
Most recent Zeus Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840012 | INDIRECT FLUORESCENT ANTIBODY MYCO | GRZ | 1984-02-27 | 54 |
| K831026 | INDIRECT FLUORESCENT ANTIBODY REAGENTS | LHL | 1983-06-22 | 84 |
| K830783 | VERI-STAPH | JWX | 1983-04-08 | 28 |
| K822859 | DIRECT FA CONJUGATE FOR LEGIONELLA SPP | LHL | 1983-02-16 | 142 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P860015 | PMA | FLUORO-CEP{R} ESTROGEN ASSAY REAGENT | 1988-02-29 |
Recalls
openFDA lists no recalls under a recalling firm named Zeus Technologies.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Zeus Technologies have?
Zeus Technologies has 4 FDA 510(k) clearances (first 1983, latest 1984), plus 1 PMA decision, across 4 product codes in 2 review panels.
How long does FDA take to clear Zeus Technologies's 510(k)s?
The median time from FDA receipt to decision across Zeus Technologies's cleared 510(k)s is 69 days.
What devices does Zeus Technologies make?
Its most frequent FDA product codes are LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, 2); GRZ (Antisera, Fluorescent, All, Mycoplasma Spp., 1); JWX (Kit, Screening, Staphylococcus Aureus, 1).
Has Zeus Technologies had device recalls?
openFDA lists no recalls under a recalling firm name matching Zeus Technologies. Related entities may recall under other names.
Next steps
- See all 4 Zeus Technologies clearances with predicates and recalls
- Run predicate analysis for product code LHL, Zeus Technologies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.