Val Tech Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Val Tech Diagnostics, Inc.” (first 1987, latest 1988), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| LJG | Quality Control Slides | 6 | 6 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 | 1 |
Review panels
- Microbiology (7)
- Immunology (4)
Most recent Val Tech Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883571 | HISTO-CHECK PARASITIC CONTROL SLIDES | LJG | 1988-10-06 | 45 |
| K883570 | HISTO-CHECK FUNGAL CONTROL SLIDES | LJG | 1988-10-06 | 45 |
| K883569 | HISTO-CHECK GRAM NEGATIVE SLIDES | LJG | 1988-10-06 | 45 |
| K883568 | HISTO-CHECK ACID FAST SLIDES | LJG | 1988-10-06 | 45 |
| K883567 | HISTO-CHECK LEGIONELLA CONTROL SLIDES | LJG | 1988-10-06 | 45 |
| K883684 | HERPES VIRUS CONTROL SLIDES | GQN | 1988-09-28 | 30 |
| K883232 | HISTONE REACTIVE ANA | LLL | 1988-09-07 | 37 |
| K883208 | HISTO-CHECK SLIDES | LJG | 1988-08-25 | 27 |
| K871395 | DUAL SUBSTRATE ANA | DHN | 1987-04-20 | 13 |
| K864668 | ANA TEST KIT | LKJ | 1987-03-12 | 100 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Val Tech Diagnostics, 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 Val Tech Diagnostics, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Val Tech Diagnostics, Inc.” (first 1987, latest 1988), 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 Val Tech Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Val Tech Diagnostics, Inc. is 45 days.
Which FDA product codes appear under Val Tech Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are LJG (Quality Control Slides, 6); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, 1).
Next steps
- See all 11 Val Tech Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJG, Val Tech Diagnostics, 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.