Leeco Diagnostics, Inc.: FDA clearances and approvals
Leeco Diagnostics, Inc. has 49 FDA 510(k) clearances (first 1979, latest 1989), across 23 product codes in 4 review panels. Median 510(k) review time: 36 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 10 | 10 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 4 | 4 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 | 4 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 3 | 3 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 2 | 2 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
Plus 13 more product codes.
Review panels
- Clinical Chemistry (40)
- Microbiology (4)
- Hematology (2)
- Immunology (2)
Most recent Leeco Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K895765 | LEECO PREVIEW(R) EBV (EIA) | KTN | 1989-10-31 | 35 |
| K894122 | LEECO VIS-DISK STREP-A (EIA) | GTZ | 1989-08-15 | 64 |
| K891096 | VIS-DISK HCG (EIA) JPL-041M | DHA | 1989-06-16 | 106 |
| K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M | DHA | 1989-06-16 | 106 |
| K883269 | PRL-QUANT | CFT | 1988-09-13 | 41 |
| K880577 | CONCEP-7-BHCG | JHI | 1988-03-15 | 34 |
| K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 | LCX | 1988-02-11 | 31 |
| K870259 | VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 | JHI | 1987-03-10 | 46 |
| K864170 | LEECO VIS-CUBE STREP A (EIA) | GTZ | 1987-02-03 | 102 |
| K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 | LCX | 1987-01-09 | 87 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Leeco Diagnostics, 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 Leeco Diagnostics, Inc. have?
Leeco Diagnostics, Inc. has 49 FDA 510(k) clearances (first 1979, latest 1989), across 23 product codes in 4 review panels.
How long does FDA take to clear Leeco Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Leeco Diagnostics, Inc.'s cleared 510(k)s is 36 days.
What devices does Leeco Diagnostics, Inc. make?
Its most frequent FDA product codes are JHI (Visual, Pregnancy Hcg, Prescription Use, 10); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 4); CEP (Radioimmunoassay, Luteinizing Hormone, 4).
Has Leeco Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Leeco Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 49 Leeco Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Leeco Diagnostics, 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.