Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Environmental Chemical Specialties — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
90 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K812635 | ANEMIA CONTROL | Environmental Chemical Specialties | 1981-10-02 | 17 | 0 |
| K811810 | URIC ACID TEST | Environmental Chemical Specialties | 1981-07-15 | 20 | 0 |
| K811809 | ANTI-ARRHYTHMIC CONTROL LEVELS I & II | Environmental Chemical Specialties | 1981-07-10 | 15 | 0 |
| K811811 | TDM ANTI-CONVULSANT CONTROL LEVELS I-II | Environmental Chemical Specialties | 1981-07-10 | 15 | 0 |
| K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) | Environmental Chemical Specialties | 1981-01-02 | 25 | 0 |
| K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL | Environmental Chemical Specialties | 1980-09-26 | 305 | 0 |
| K801854 | SPINAL FLUID CONTROL(HUMAN) | Environmental Chemical Specialties | 1980-09-16 | 43 | 0 |
| K801061 | TOTAL PROTEIN TEST | Environmental Chemical Specialties | 1980-07-21 | 76 | 0 |
| K792374 | QUANTITATIVE CONTROL URINE I (HUMAN) | Environmental Chemical Specialties | 1979-12-06 | 10 | 0 |
| K792375 | ELEVATED LIPID CONTROL | Environmental Chemical Specialties | 1979-12-06 | 10 | 0 |
| K792376 | QUANTITATIVE CONTROL URINE II (HUMAN) | Environmental Chemical Specialties | 1979-12-06 | 10 | 0 |
| K780173 | LYPOPROTEIN CHOLESTEROL TEST KIT | Environmental Chemical Specialties | 1978-05-03 | 90 | 0 |
| K771067 | CHOLESTEROL KIT | Environmental Chemical Specialties | 1977-07-21 | 38 | 0 |
| K771068 | TRIGLYCERIDE KIT | Environmental Chemical Specialties | 1977-07-12 | 29 | 0 |
| K761320 | GLUCOSE KIT | Environmental Chemical Specialties | 1977-01-25 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda