DLI
6 FDA 510(k) clearances · Product code
78 daysmedian time to decision
95 days90th percentile
6clearances measured
FDA profile
- Official device name
- Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3240
- Medical specialty
- Clinical Toxicology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD (K950180) | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-15 |
| CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO (K930208) | Heraeus Kulzer, Inc. | 1993-04-20 |
| SERUM CHOLINESTERASE REAGENT SET (K860350) | Sterling Diagnostics, Inc. | 1986-04-24 |
| EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 (K860641) | Em Diagnostic Systems, Inc. | 1986-04-03 |
| SERUM CHOLINESTERASE REAGENT SET (K833062) | Sterling Biochemical, Inc. | 1983-11-25 |
| CHOLINESTERASE REAGENT SYSTEM (K771024) | American Monitor Corp. | 1977-07-15 |
Track DLI automatically
Every clearance here is in the API, with alerts when new ones post.