Elias U.S.A., Inc.: FDA clearances and approvals
Elias U.S.A., Inc. has 54 FDA 510(k) clearances (first 1992, latest 1997), across 21 product codes in 3 review panels. Median 510(k) review time: 118 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 16 | 16 |
| MID | System, Test, Anticardiolipin Immunological | 7 | 7 |
| JZO | System, Test, Thyroid Autoantibody | 5 | 5 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 4 | 4 |
| LKJ | Antinuclear Antibody, Antigen, Control | 3 | 3 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 2 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| DBJ | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
Plus 11 more product codes.
Review panels
- Immunology (49)
- Clinical Chemistry (4)
- Microbiology (1)
Most recent Elias U.S.A., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964385 | ELIAS ANA-HEP-2 | LJM | 1997-03-06 | 122 |
| K963291 | VARELISA ANA (4) PROFILE | LJM | 1996-09-30 | 40 |
| K953873 | VARELISA HELICOBACTER PYLORI ANTIBODIES | LYR | 1996-08-30 | 379 |
| K953587 | VARELISA MPO-ANCA | MOB | 1996-01-26 | 178 |
| K953586 | VARELISA PR3-ANCA | MOB | 1996-01-26 | 178 |
| K951187 | VARELISA CARDIOLIPIN ABS SCREEN | MID | 1995-10-02 | 200 |
| K951207 | VARELISA HISTONE ANTIBODIES | LJM | 1995-04-17 | 31 |
| K951206 | VARELISA PARIETAL CELL ANTIBODIES | MLE | 1995-04-17 | 31 |
| K951205 | VARELISA ANA PROFILE | LJM | 1995-04-17 | 31 |
| K951186 | VARELISA ANA-4 SCREEN | LJM | 1995-04-17 | 32 |
44 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Elias U.S.A., Inc..
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 Elias U.S.A., Inc. have?
Elias U.S.A., Inc. has 54 FDA 510(k) clearances (first 1992, latest 1997), across 21 product codes in 3 review panels.
How long does FDA take to clear Elias U.S.A., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Elias U.S.A., Inc.'s cleared 510(k)s is 118 days.
What devices does Elias U.S.A., Inc. make?
Its most frequent FDA product codes are LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 16); MID (System, Test, Anticardiolipin Immunological, 7); JZO (System, Test, Thyroid Autoantibody, 5).
Has Elias U.S.A., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Elias U.S.A., Inc. Related entities may recall under other names.
Next steps
- See all 54 Elias U.S.A., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJM, Elias U.S.A., Inc.'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.