Bionetic Laboratory Products: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Bionetic Laboratory Products” (first 1983, latest 1984), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| JTQ | Bath, Incubators/Water, All | 2 | 2 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | 2 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 | 1 |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 1 | 1 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 1 | 1 |
| LJK | Antisera, If, Toxoplasma Gondii | 1 | 1 |
Review panels
- Microbiology (8)
Most recent Bionetic Laboratory Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833637 | VZV BIO-ENZABEAD SCREEN KIT | LFY | 1984-02-10 | 116 |
| K832900 | IMMUNOENZYME TEST SYS-DETECT-IGM ANTI | GLZ | 1983-11-14 | 77 |
| K832069 | TOXO IPA KIT IAN INDIRECT FLUORESCENT | LJK | 1983-09-26 | 91 |
| K831760 | LEGIONELLA IFA KIT I | LHL | 1983-08-08 | 68 |
| K831133 | AMEBIASIS BIO-ENZABEAD SCREEN KIT | KHW | 1983-06-08 | 62 |
| K830820 | LEGIONELLA DFA KIT I | LHL | 1983-06-08 | 85 |
| K830405 | LBI-100 37DEGREES INCUBATOR | JTQ | 1983-03-10 | 31 |
| K830227 | AUTOMATED ELISA READER LBI 300 | JTQ | 1983-03-10 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Bionetic Laboratory Products.
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 Bionetic Laboratory Products?
FDA lists 8 510(k) clearances under the applicant name “Bionetic Laboratory Products” (first 1983, latest 1984), across 6 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 Bionetic Laboratory Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bionetic Laboratory Products is 72 days.
Which FDA product codes appear under Bionetic Laboratory Products?
The most frequent FDA product codes under this applicant name are JTQ (Bath, Incubators/Water, All, 2); LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, 2); GLZ (Antigens, If, Toxoplasma Gondii, 1).
Next steps
- See all 8 Bionetic Laboratory Products clearances with predicates and recalls
- Run predicate analysis for product code JTQ, Bionetic Laboratory Products'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.