Toxi-Lab, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Toxi-Lab, Inc.” (first 1990, latest 1993), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 141 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | 1 | 1 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 1 | 1 |
| DML | Nad-Nadh, Specific Reagent For Alcohol Enzyme Method | 1 | 1 |
| DOJ | Potassium Dichromate, Alcohol | 1 | 1 |
| LAI | Thin Layer Chromatography, Opiates | 1 | 1 |
Review panels
Most recent Toxi-Lab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932209 | TOXI*LAB LTD OPIATE SYSTEM | LAI | 1993-09-24 | 141 |
| K923337 | ON*SITE ALCOHOL | DML | 1993-01-12 | 208 |
| K903223 | ON-SITE ALCOHOL | DOJ | 1991-03-13 | 233 |
| K901694 | SPEC(TM) EXTRACTION CARTRIDGE | DKE | 1990-06-01 | 52 |
| K900626 | ALPHA URINE SAMPLE | DIF | 1990-03-06 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Toxi-Lab, 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 Toxi-Lab, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Toxi-Lab, Inc.” (first 1990, latest 1993), across 5 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 Toxi-Lab, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Toxi-Lab, Inc. is 141 days.
Which FDA product codes appear under Toxi-Lab, Inc.?
The most frequent FDA product codes under this applicant name are DIF (Drug Mixture Control Materials, 1); DKE (Reagents, Test, Tetrahydrocannabinol, 1); DML (Nad-Nadh, Specific Reagent For Alcohol Enzyme Method, 1).
Next steps
- See all 5 Toxi-Lab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIF, Toxi-Lab, 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.