Ventrex Laboratories, Inc.: FDA filings under this applicant name
FDA lists 82 510(k) clearances under the applicant name “Ventrex Laboratories, Inc.” (first 1979, latest 1992), across 39 product codes in 6 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 18 | 18 |
| DGC | Ige, Antigen, Antiserum, Control | 12 | 12 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 | 4 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 4 | 4 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 2 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 2 | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 | 2 |
| JIT | Calibrator, Secondary | 2 | 2 |
Plus 29 more product codes.
Review panels
- Clinical Chemistry (34)
- Immunology (34)
- Clinical Toxicology (5)
- Microbiology (4)
- Hematology (2)
- Pathology (2)
Most recent Ventrex Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914554 | SPECIFIC IGE EIA-TURBO ASSAY | DHB | 1992-03-13 | 154 |
| K913833 | VENTREX ALLERGEN DISC | DHB | 1992-02-21 | 179 |
| K913434 | VENTREX COATED TUBE INTACT PTH | CEW | 1991-10-25 | 85 |
| K905612 | VENTREX COATED TUBE IGE RADIOIMMUNOASSAY | DGC | 1991-02-21 | 69 |
| K905636 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY | DHB | 1991-02-07 | 52 |
| K905247 | SHBG IRMA KIT | CDZ | 1991-01-17 | 57 |
| K904330 | TURBO-RAST SPECIFIC IGE ASSAY | DHB | 1990-12-07 | 78 |
| K903000 | TURBO-RAST SPECIFIC IGE ASSAY | JHR | 1990-07-31 | 22 |
| K897083 | VENTRESIGN STREP A TEST | GTZ | 1990-01-22 | 33 |
| K895649 | COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. | JIT | 1990-01-18 | 120 |
72 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ventrex Laboratories, Inc..
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.
- Ventrex, Inc. (5 510(k)s)
- Ventrex, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ventrex Laboratories, Inc.?
FDA lists 82 510(k) clearances under the applicant name “Ventrex Laboratories, Inc.” (first 1979, latest 1992), across 39 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ventrex Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ventrex Laboratories, Inc. is 40 days.
Which FDA product codes appear under Ventrex Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 18); DGC (Ige, Antigen, Antiserum, Control, 12); JHI (Visual, Pregnancy Hcg, Prescription Use, 4).
Next steps
- See all 82 Ventrex Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHB, Ventrex Laboratories, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.