Biohytech International, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Biohytech International, Inc.” (first 1986, latest 1987), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 6 | 6 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
Review panels
- Immunology (7)
Most recent Biohytech International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870453 | DS-DNA EIA DIAGNOSTIC KIT | LJM | 1987-03-24 | 62 |
| K870458 | HISTONES EIA DIAGNOSTIC KIT | DHN | 1987-03-17 | 55 |
| K870457 | RNP EIA DIAGNOSTIC KIT | LJM | 1987-03-17 | 55 |
| K870456 | DNP EIA DIAGNOSTIC KIT | LJM | 1987-03-17 | 55 |
| K870455 | SM EIA DIAGNOSTIC KIT | LJM | 1987-03-17 | 55 |
| K870452 | SS-DNA EIA DIAGNOSTIC KIT | LJM | 1987-03-17 | 55 |
| K862969 | ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT | LJM | 1986-10-24 | 79 |
Recalls
openFDA lists no recalls under a recalling firm named Biohytech International, 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 Biohytech International, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Biohytech International, Inc.” (first 1986, latest 1987), across 2 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 Biohytech International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biohytech International, Inc. is 55 days.
Which FDA product codes appear under Biohytech International, Inc.?
The most frequent FDA product codes under this applicant name are LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 6); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 1).
Next steps
- See all 7 Biohytech International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJM, Biohytech International, 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.