Biogenex Laboratories: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Biogenex Laboratories” (first 1981, latest 2002), plus 1 PMA decision, across 7 product codes in 2 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 | 5 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 | 2 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 2 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| MVC | System, Test, Her-2/Neu, Ihc | 1 | 0 |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 1 | 1 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 1 | 1 |
Review panels
- Clinical Chemistry (10)
- Pathology (3)
Most recent Biogenex Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | MXZ | 2002-03-08 | 185 |
| K013148 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) | MYA | 2002-02-28 | 161 |
| K925189 | PREGNAGEN 1-STEP PREGNANCY TEST | LCX | 1993-01-06 | 85 |
| K902208 | MODIFIED OVUGEN | CEP | 1990-07-17 | 62 |
| K884880 | PREGNAGEN(TM) | JHI | 1989-01-13 | 53 |
| K882002 | PREGNAGEN(TM) | JHI | 1988-09-09 | 119 |
| K873534 | OVUGEN SURETEST | CEP | 1987-11-23 | 83 |
| K831221 | RIAGEN B-HCG RIA KIT | JHI | 1983-06-02 | 48 |
| K821657 | RIAGEN B-HCG RIA | JHI | 1982-07-13 | 39 |
| K821234 | RIAGEN B-HCG RIA | JHI | 1982-05-21 | 23 |
2 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040030 | PMA | INSITE HER-2/NEU KIT | 2004-12-22 |
Recalls
11 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2014-07-01.
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 Biogenex Laboratories?
FDA lists 12 510(k) clearances under the applicant name “Biogenex Laboratories” (first 1981, latest 2002), plus 1 PMA decision, across 7 product codes in 2 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 Biogenex Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biogenex Laboratories is 58 days.
Which FDA product codes appear under Biogenex Laboratories?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 5); CEP (Radioimmunoassay, Luteinizing Hormone, 2); JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited, 2).
Next steps
- See all 12 Biogenex Laboratories clearances with predicates and recalls
- Run predicate analysis for product code JHI, Biogenex Laboratories'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.