Company ยท US
Environmental Chemical Specialties
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1981. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DIF | Drug Mixture Control Materials | 2 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 |
| JGM | Flame Photometry, Potassium | 1 |
| JHM | Colorimetric Method, Lipoproteins | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 1981 | K812635 | ANEMIA CONTROL Environmental Chemical Specialties | JJY |
| Jul 15, 1981 | K811810 | URIC ACID TEST Environmental Chemical Specialties | KNK |
| Jul 10, 1981 | K811811 | TDM ANTI-CONVULSANT CONTROL LEVELS I-II Environmental Chemical Specialties | DIF |
| Jul 10, 1981 | K811809 | ANTI-ARRHYTHMIC CONTROL LEVELS I & II Environmental Chemical Specialties | DIF |
| Jan 2, 1981 | K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) Environmental Chemical Specialties | JPZ |
| Sep 26, 1980 | K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL Environmental Chemical Specialties | DHX |
| Sep 16, 1980 | K801854 | SPINAL FLUID CONTROL(HUMAN) Environmental Chemical Specialties | JJX |
| Jul 21, 1980 | K801061 | TOTAL PROTEIN TEST Environmental Chemical Specialties | CEK |
| Dec 6, 1979 | K792376 | QUANTITATIVE CONTROL URINE II (HUMAN) Environmental Chemical Specialties | JJW |
| Dec 6, 1979 | K792375 | ELEVATED LIPID CONTROL Environmental Chemical Specialties | JJY |
| Dec 6, 1979 | K792374 | QUANTITATIVE CONTROL URINE I (HUMAN) Environmental Chemical Specialties | JJW |
| May 3, 1978 | K780173 | LYPOPROTEIN CHOLESTEROL TEST KIT Environmental Chemical Specialties | JHM |
| Jul 21, 1977 | K771067 | CHOLESTEROL KIT Environmental Chemical Specialties | CHH |
| Jul 12, 1977 | K771068 | TRIGLYCERIDE KIT Environmental Chemical Specialties | JGM |
| Jan 25, 1977 | K761320 | GLUCOSE KIT Environmental Chemical Specialties | CFR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||