Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Acetylcholine Chloride as a Specific Reagent for Pseudocholinesterase is a laboratory reagent used in enzymatic assays to measure pseudocholinesterase activity in patient specimens, which can indicate organophosphate poisoning or genetic enzyme deficiencies. It is a Class 1 device subject to general controls only, with no premarket notification required. The product code is DLI, regulated under 21 CFR 862.3240, within the Clinical Toxicology specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- DLI
- Device Class
- FDA class 1
- Regulation Number
- 862.3240
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950180 | DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD | Mar 15, 1995 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K930208 | CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO | Apr 20, 1993 | Substantially Equivalent | Heraeus Kulzer, Inc. |
| K860350 | SERUM CHOLINESTERASE REAGENT SET | Apr 24, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K860641 | EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 | Apr 03, 1986 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K833062 | SERUM CHOLINESTERASE REAGENT SET | Nov 25, 1983 | Substantially Equivalent | Sterling Biochemical, Inc. |
| K771024 | CHOLINESTERASE REAGENT SYSTEM | Jul 15, 1977 | Substantially Equivalent | American Monitor Corp. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.