Savyon Diagnostics , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Savyon Diagnostics , Ltd.” (first 1991, latest 1992), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 208 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 |
|---|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 2 | 2 |
| LKH | Antisera, Immunoperoxidase, Chlamydia Spp. | 2 | 2 |
| JXA | Kit, Screening, Urine | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Savyon Diagnostics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921045 | DIASLIDE URINE CULTURING DEVICE | JXA | 1992-09-28 | 208 |
| K914327 | SEROELISA(TM) CHLAMYDIA IGA TEST KIT | LJC | 1992-06-09 | 256 |
| K915281 | SEROLISA CHLAMYDIA IGG TEST KIT | LJC | 1992-03-23 | 119 |
| K910644 | IPAZYME (TM) CHLAMYDIA IGG-IGA | LKH | 1991-03-19 | 33 |
| K901975 | IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) | LKH | 1991-03-08 | 311 |
Recalls
openFDA lists no recalls under a recalling firm named Savyon Diagnostics , Ltd..
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 Savyon Diagnostics , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Savyon Diagnostics , Ltd.” (first 1991, latest 1992), across 3 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 Savyon Diagnostics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Savyon Diagnostics , Ltd. is 208 days.
Which FDA product codes appear under Savyon Diagnostics , Ltd.?
The most frequent FDA product codes under this applicant name are LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), 2); LKH (Antisera, Immunoperoxidase, Chlamydia Spp., 2); JXA (Kit, Screening, Urine, 1).
Next steps
- See all 5 Savyon Diagnostics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LJC, Savyon Diagnostics , Ltd.'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.