FDA product code DLI: Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
DLI is the FDA product code for acetylcholine chloride, specific reagent for pseudo cholinesterase. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel. FDA has cleared 6 510(k) submissions under DLI, from 6 different applicants. The average 510(k) review took 66 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase |
| Device class | Class I |
| Regulation | 21 CFR 862.3240 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DLI clearance
Top DLI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1995-03-15 |
| Heraeus Kulzer, Inc. | 1 | 1993-04-20 |
| Sterling Diagnostics, Inc. | 1 | 1986-04-24 |
| Em Diagnostic Systems, Inc. | 1 | 1986-04-03 |
| Sterling Biochemical, Inc. | 1 | 1983-11-25 |
1 more applicants have DLI clearances. See the full list in Caduvo.
Most recent DLI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950180 | E.I. Dupont DE Nemours & Co., Inc. | DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD | 1995-03-15 | 57 |
| K930208 | Heraeus Kulzer, Inc. | CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO | 1993-04-20 | 95 |
| K860350 | Sterling Diagnostics, Inc. | SERUM CHOLINESTERASE REAGENT SET | 1986-04-24 | 84 |
| K860641 | Em Diagnostic Systems, Inc. | EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 | 1986-04-03 | 42 |
| K833062 | Sterling Biochemical, Inc. | SERUM CHOLINESTERASE REAGENT SET | 1983-11-25 | 78 |
Recalls for DLI devices
openFDA lists no recalls for product code DLI.
Frequently asked questions
What is FDA product code DLI?
DLI is the FDA product code for acetylcholine chloride, specific reagent for pseudo cholinesterase. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel.
What device class is DLI?
Class I, regulation 21 CFR 862.3240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DLI?
Across 6 cleared submissions the average was 66 days from receipt to decision (median 68).
Which companies have the most DLI clearances?
E.I. Dupont DE Nemours & Co., Inc. (1); Heraeus Kulzer, Inc. (1); Sterling Diagnostics, Inc. (1); Em Diagnostic Systems, Inc. (1); Sterling Biochemical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DLI
- Run a recall and safety report across every DLI manufacturer
- Watch product code DLI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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