Environmental Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Environmental Diagnostics, Inc.” (first 1987, latest 1991), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 | 1 |
Review panels
Most recent Environmental Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905700 | EZ-SCREEN: AMPHETAMINES | DKZ | 1991-01-15 | 26 |
| K905057 | EZ-SCREEN:BARBITURATES | DIS | 1990-11-28 | 20 |
| K902681 | EZ-SCREEN:HCG | JHI | 1990-08-09 | 51 |
| K900203 | EZ-SCREEN:OPIATES | DJG | 1990-03-09 | 52 |
| K883105 | EZ-SCREEN CANNABINOID/COCAINE | DIO | 1988-12-16 | 144 |
| K862916 | EZ-SCREEN: CANNABINOID | KLT | 1987-01-07 | 159 |
Recalls
openFDA lists no recalls under a recalling firm named Environmental 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Environmental Chemical Specialties (15 510(k)s)
- Environmental Test Systems, Inc. (8 510(k)s)
- Environmental Tectonics Corp. (3 510(k)s)
- Environmental Sciences Assoc., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Environmental Diagnostics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Environmental Diagnostics, Inc.” (first 1987, latest 1991), across 6 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 Environmental Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Environmental Diagnostics, Inc. is 52 days.
Which FDA product codes appear under Environmental Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DIS (Enzyme Immunoassay, Barbiturate, 1); DJG (Enzyme Immunoassay, Opiates, 1).
Next steps
- See all 6 Environmental Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Environmental 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, 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.