Beckman Cholinesterase Reagent Kit
FDA 510(k) K893583 · Beckman
510(k) numberK893583
Submission
- Device name
- Beckman Cholinesterase Reagent Kit
- Applicant
- Beckman
Brea, CA, US - Received
- May 9, 1989
- Decision date
- August 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIH – Colorimetry, Cholinesterase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3240
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K103373 | Synchron Systems Cholinesterase (Chex) Model A53722DIH · Traditional | Beckman Coulter, Inc. | 02/07/2011SE |
| K061093 | Cholinesterase GEN.2 Test SystemDIH · Traditional | Roche Diagnostics Corp. | 07/03/2006SE |
| K051444 | Sentinel Cholinesterase LiquidDIH · Special | Sentinel Ch. Srl | 06/20/2005SE |
| K030045 | Olympus Cholinesterase Reagent (Catalog Number OSR6114)DIH · Traditional | Olympus America, Inc. | 02/21/2003SE |
| K023992 | Wiener Lab Colinesterasa AaDIH · Traditional | Wiener Laboratories Saic | 02/12/2003SE |
| K013750 | Advia 1650 Cholinesterase AssayDIH · Traditional | Bayer Diagnostics Corp. | 01/18/2002SE |
| K002792 | Careside CholinesteraseDIH · Traditional | Careside, Inc. | 11/08/2000SE |
| K001344 | Advia ImsDIH · Traditional | Bayer Corp. | 06/26/2000SE |
| K961656 | Test-Mate Che Cholinesterase Test SystemDIH · Traditional | Eqm Research, Inc. | 11/26/1996SE |
| K943367 | Il Test CholinesteraseDIH · Traditional | Instrumentation Laboratory CO | 02/05/1996SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K991707 | Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models…DHX · Special | 06/01/1999SE |
| K971534 | Synchron Syustems Dat Drug Free Urine ControlDIF · Traditional | 05/21/1997SE |
| K935362 | P-Amylase ControlJJX · Traditional | 01/27/1994SE |
| K904219 | Synchron CX 7 Clinical AnalyzerJJE · Traditional | 10/22/1990SE |
| K904220 | Synchron CX4-CEJJE · Traditional | 10/15/1990SE |
Questions and answers
When was Beckman Cholinesterase Reagent Kit cleared by the FDA?
Beckman Cholinesterase Reagent Kit (K893583) received a 510(k) decision of Substantially Equivalent on August 15, 1989, 98 days after the submission was received.
What is the product code of K893583?
The FDA product code is DIH – Colorimetry, Cholinesterase, a Class I (low risk) device regulated under 21 CFR 862.3240.