Institute Virion , Ltd.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Institute Virion , Ltd.” (first 1984, latest 1986), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 374 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 |
|---|---|---|---|
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 2 | 2 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 2 | 2 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 1 | 1 |
| GPS | Antigen, Cf, Q Fever | 1 | 1 |
| GPW | Antigen, Cf, Psittacosis (Chlamydia Group) | 1 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 1 | 1 |
| GRJ | Antigen, Cf, (Including Cf Control), Rubeola | 1 | 1 |
Plus 4 more product codes.
Review panels
- Microbiology (15)
- Clinical Chemistry (1)
Most recent Institute Virion , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862814 | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI | LQP | 1986-09-30 | 68 |
| K843676 | VARICELLA/ZOSTER VIRUS | GQW | 1985-09-26 | 374 |
| K843673 | RESPIRATORY SYNCYTIAL VIRUS | GQG | 1985-09-26 | 374 |
| K843667 | PARAINFLUENZA 3 | GQS | 1985-09-26 | 374 |
| K843665 | PARAINFLUENZA 1 | GQS | 1985-09-26 | 374 |
| K843662 | MEASLES VIRUS RUBEOLA | GRJ | 1985-09-26 | 374 |
| K843660 | IN FLUENZA B VIRUS | GNX | 1985-09-26 | 374 |
| K843659 | INFLUENZA A2 VIRUS | GNX | 1985-09-26 | 374 |
| K843658 | H. SIMPLEX VIRUS | GQN | 1985-09-26 | 374 |
| K843657 | CYTOMEGALOVIRUS | GQH | 1985-09-26 | 374 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Institute Virion , Ltd..
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 Institute Virion , Ltd. (a text match, not an official crosswalk):
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.
- Institute For Clinical Applications (1 510(k)s)
- Institute For Quality Resource Management (1 510(k)s)
- Institute of Logopedics (1 510(k)s)
- Institute of Musculoskeletal Science & Education (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Institute Virion , Ltd.?
FDA lists 16 510(k) clearances under the applicant name “Institute Virion , Ltd.” (first 1984, latest 1986), across 14 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 Institute Virion , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Institute Virion , Ltd. is 374 days.
Which FDA product codes appear under Institute Virion , Ltd.?
The most frequent FDA product codes under this applicant name are GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C, 2); GQS (Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4, 2); GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33, 1).
Next steps
- See all 16 Institute Virion , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GNX, Institute Virion , Ltd.'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.