Environmental Chemical Specialties: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Environmental Chemical Specialties” (first 1977, latest 1981), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 25 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 | 2 | 2 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 | 1 |
| JGM | Flame Photometry, Potassium | 1 | 1 |
| JHM | Colorimetric Method, Lipoproteins | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (12)
- Clinical Toxicology (2)
- Immunology (1)
Most recent Environmental Chemical Specialties 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812635 | ANEMIA CONTROL | JJY | 1981-10-02 | 17 |
| K811810 | URIC ACID TEST | KNK | 1981-07-15 | 20 |
| K811811 | TDM ANTI-CONVULSANT CONTROL LEVELS I-II | DIF | 1981-07-10 | 15 |
| K811809 | ANTI-ARRHYTHMIC CONTROL LEVELS I & II | DIF | 1981-07-10 | 15 |
| K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) | JPZ | 1981-01-02 | 25 |
| K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL | DHX | 1980-09-26 | 305 |
| K801854 | SPINAL FLUID CONTROL(HUMAN) | JJX | 1980-09-16 | 43 |
| K801061 | TOTAL PROTEIN TEST | CEK | 1980-07-21 | 76 |
| K792376 | QUANTITATIVE CONTROL URINE II (HUMAN) | JJW | 1979-12-06 | 10 |
| K792375 | ELEVATED LIPID CONTROL | JJY | 1979-12-06 | 10 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Environmental Chemical Specialties.
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 Test Systems, Inc. (8 510(k)s)
- Environmental Diagnostics, Inc. (6 510(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 Chemical Specialties?
FDA lists 15 510(k) clearances under the applicant name “Environmental Chemical Specialties” (first 1977, latest 1981), across 12 product codes in 3 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 Chemical Specialties?
The median time from FDA receipt to decision across 510(k)s cleared under the name Environmental Chemical Specialties is 25 days.
Which FDA product codes appear under Environmental Chemical Specialties?
The most frequent FDA product codes under this applicant name are DIF (Drug Mixture Control Materials, 2); JJW (Urinalysis Controls (Assayed And Unassayed), 2); JJY (Multi-Analyte Controls, All Kinds (Assayed), 2).
Next steps
- See all 15 Environmental Chemical Specialties clearances with predicates and recalls
- Run predicate analysis for product code DIF, Environmental Chemical Specialties'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.