Serum Cholinesterase Reagent Set
FDA 510(k) K833062 · Sterling Biochemical, Inc.
510(k) numberK833062
Submission
- Device name
- Serum Cholinesterase Reagent Set
- Applicant
- Sterling Biochemical, Inc.
Mchenry, IL, US - Received
- September 8, 1983
- Decision date
- November 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLI – Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3240
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DLI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950180 | Dupont Dimension(R) Pseudocholinesterase MethodDLI · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/15/1995SE |
| K930208 | Cholinesterase Method for Technicon CHEM1/TECHNICODLI · Traditional | Heraeus Kulzer, Inc. | 04/20/1993SE |
| K860350 | Serum Cholinesterase Reagent SetDLI · Traditional | Sterling Diagnostics, Inc. | 04/24/1986SE |
| K860641 | Easy-Test (Che) Reagent, Item No. 67522/93DLI · Traditional | Em Diagnostic Systems, Inc. | 04/03/1986SE |
| K771024 | Cholinesterase Reagent SystemDLI · Traditional | American Monitor Corp. | 07/15/1977SE |
More from American Monitor Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K844998 | Glucose(Hexokinase) Reagent SetCFR · Traditional | 01/18/1985SE |
| K844251 | Alt/Gpt Reagent SetCKA · Traditional | 01/08/1985SE |
| K843332 | Alkaline Phosphatase Reagent SetCJE · Traditional | 09/14/1984SE |
| K842521 | Ast/Got Reagent Set UV RateCIT · Traditional | 08/12/1984SE |
| K840064 | Urea Nitrogen Reagent SetCDQ · Traditional | 06/14/1984SE |
| K834084 | Hydroxybutyrate Dehydrogenase ReagentJKF · Traditional | 02/04/1984SE |
| K834045 | Uric Acid Reagent SetKNK · Traditional | 01/30/1984SE |
| K833864 | Amylase Reagent Set-Modified CarawayCJA · Traditional | 01/13/1984SE |
| K831874 | Lipase Reagent SetJGX · Traditional | 08/12/1983SE |
| K831415 | Lactic Dehydrogenase Reagent SetCFJ · Traditional | 06/16/1983SE |
Questions and answers
When was Serum Cholinesterase Reagent Set cleared by the FDA?
Serum Cholinesterase Reagent Set (K833062) received a 510(k) decision of Substantially Equivalent on November 25, 1983, 78 days after the submission was received.
What is the product code of K833062?
The FDA product code is DLI – Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase, a Class I (low risk) device regulated under 21 CFR 862.3240.