Neogenex: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Neogenex” (first 1994, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 111 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 |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 15 | 15 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 2 | 2 |
| GQI | Antiserum, Cf, Cytomegalovirus | 1 | 1 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 | 1 |
Review panels
- Pathology (15)
- Microbiology (5)
Most recent Neogenex 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965047 | MINK LUNG CELL CULTURE | KIR | 1997-02-04 | 48 |
| K960909 | H292 CELL CULTURE | KIR | 1996-05-30 | 86 |
| K943891 | RD CULTURE CELL | KIR | 1994-11-28 | 111 |
| K943890 | WI38 CELL CULTURE | KIR | 1994-11-28 | 111 |
| K943889 | VERO CELL CULTURE | KIR | 1994-11-28 | 111 |
| K943888 | MDCK CELL CULTURE | KIR | 1994-11-28 | 111 |
| K943887 | HUMAN NEWBORN FORESKIN CELL CULTURE | KIR | 1994-11-28 | 111 |
| K943886 | BGM CELL CULTURE | KIR | 1994-11-28 | 111 |
| K943885 | PRIMARY RABBIT KIDNEY CELL CULTURE | KIR | 1994-11-28 | 111 |
| K943884 | PRIMARY MONKEY KIDNEY CELL CULTURE | KIR | 1994-11-28 | 111 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Neogenex.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Neogenex (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNW)
- Q2039 — Influenza virus vaccine, not otherwise specified (via GNW)
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu) (via GNW)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neogenex?
FDA lists 20 510(k) clearances under the applicant name “Neogenex” (first 1994, latest 1997), across 5 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 Neogenex?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neogenex is 111 days.
Which FDA product codes appear under Neogenex?
The most frequent FDA product codes under this applicant name are KIR (Cells, Animal And Human, Cultured, 15); GNW (Antisera, Cf, Influenza Virus A, B, C, 2); GQI (Antiserum, Cf, Cytomegalovirus, 1).
Next steps
- See all 20 Neogenex clearances with predicates and recalls
- Run predicate analysis for product code KIR, Neogenex'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.