Virion (U.S.), Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Virion (U.S.), Inc.” (first 1987, latest 1994), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 201 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 |
|---|---|---|---|
| GMN | Antigens, Cf, Toxoplasma Gondii | 1 | 1 |
| GNG | Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6 | 1 | 1 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 1 | 1 |
| GRC | Antigen, Cf (Including Cf Control), Mumps Virus | 1 | 1 |
| MCD | Antigen, Ebv, Capsid | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Virion (U.S.), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933251 | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST | MCD | 1994-06-13 | 346 |
| K921618 | COXSACKIE VIRUS B1-B6 CF ANTIGENS | GNG | 1992-06-29 | 84 |
| K905306 | MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN | GRC | 1991-06-17 | 201 |
| K905385 | P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN | GQS | 1991-03-21 | 111 |
| K864981 | TOXOPLASMA GONDII | GMN | 1987-10-30 | 312 |
Recalls
openFDA lists no recalls under a recalling firm named Virion (U.S.), 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Virion (U.S.), Inc.?
FDA lists 5 510(k) clearances under the applicant name “Virion (U.S.), Inc.” (first 1987, latest 1994), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Virion (U.S.), Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Virion (U.S.), Inc. is 201 days.
Which FDA product codes appear under Virion (U.S.), Inc.?
The most frequent FDA product codes under this applicant name are GMN (Antigens, Cf, Toxoplasma Gondii, 1); GNG (Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6, 1); GQS (Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4, 1).
Next steps
- See all 5 Virion (U.S.), Inc. clearances with predicates and recalls
- Run predicate analysis for product code GMN, Virion (U.S.), 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.