Elite Diagnostic , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Elite Diagnostic , Ltd.” (first 1989, latest 1989), across 4 product codes in 1 review panel. 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 |
|---|---|---|---|
| GFO | Activated Partial Thromboplastin | 2 | 2 |
| GGL | Control, White-Cell | 1 | 1 |
| GIZ | Plasma, Control, Normal | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
Review panels
- Hematology (5)
Most recent Elite Diagnostic , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891370 | EDL ONE-STAGE PROTHROMBIN TIME REAGENT | GJS | 1989-04-21 | 43 |
| K890859 | EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME | GFO | 1989-04-21 | 59 |
| K891179 | EDL NORMAL COAGULATION CONTROL | GIZ | 1989-04-10 | 35 |
| K891175 | EDL ABNORMAL COAGULATION CONTROL | GGL | 1989-04-10 | 35 |
| K890619 | EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT | GFO | 1989-03-15 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Elite Diagnostic , 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.
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.
- Elite Technology, Inc. (5 510(k)s)
- Elite International, Inc. (4 510(k)s)
- Elite Surgical Supplies (Pty), Ltd. (4 510(k)s)
- Elite Biomedical Solutions (1 510(k)s)
- Elite Electromedical (1 510(k)s)
- Elite Medical, Inc. (1 510(k)s)
- Elite Medical Supply of New York, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Elite Diagnostic , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Elite Diagnostic , Ltd.” (first 1989, latest 1989), across 4 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 Elite Diagnostic , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elite Diagnostic , Ltd. is 36 days.
Which FDA product codes appear under Elite Diagnostic , Ltd.?
The most frequent FDA product codes under this applicant name are GFO (Activated Partial Thromboplastin, 2); GGL (Control, White-Cell, 1); GIZ (Plasma, Control, Normal, 1).
Next steps
- See all 5 Elite Diagnostic , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GFO, Elite Diagnostic , 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.