Viromed Laboratories, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Viromed Laboratories, Inc.” (first 1983, latest 1996), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 | 22 | 22 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 2 | 2 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 |
Review panels
- Pathology (24)
- Microbiology (1)
Most recent Viromed Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951461 | NCI-H292 CELL CULTURE | KIR | 1996-05-22 | 419 |
| K951440 | LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE | KIR | 1996-05-22 | 420 |
| K871613 | BUFFALO GREEN MONKEY KIDNEY CELLS | KIR | 1987-05-13 | 19 |
| K862555 | HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) | KIR | 1986-07-10 | 7 |
| K861373 | HUMAN LUNG CARCINOMA CELLS (A549) | KIR | 1986-04-18 | 7 |
| K853695 | RESPIRATORY SYNCYTIAL VIRUS ID REAGENT | GQG | 1985-12-04 | 91 |
| K852396 | HEK | KIR | 1985-07-12 | 36 |
| K852395 | MINK LUNG | KIR | 1985-07-12 | 36 |
| K852394 | MDCK | KIR | 1985-07-12 | 36 |
| K843252 | AFRICAN GREEN SV 5/SV 40 | KIR | 1984-09-06 | 17 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Viromed 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Viromed Laboratories, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Viromed Laboratories, Inc.” (first 1983, latest 1996), across 3 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 Viromed Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viromed Laboratories, Inc. is 36 days.
Which FDA product codes appear under Viromed Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are KIR (Cells, Animal And Human, Cultured, 22); KIT (Media And Components, Synthetic Cell And Tissue Culture, 2); GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, 1).
Next steps
- See all 25 Viromed Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIR, Viromed 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, 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.