Careside Cholinesterase
FDA 510(k) K002792 · Careside, Inc.
510(k) numberK002792
Submission
- Device name
- Careside Cholinesterase
- Applicant
- Careside, Inc.
Culver City, CA, US - Received
- September 7, 2000
- Decision date
- November 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K955498 | Cholinesterase Assay Kit, Catalogue# 300-05DIH · Traditional | Diagnostic Chemicals , Ltd. | 01/24/1996SE |
More from Diagnostic Chemicals , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K020484 | Careside LDHCFH · Traditional | 07/03/2002SE |
| K020486 | Careside GGTJPZ · Traditional | 07/01/2002SE |
| K020487 | Careside AltCKA · Traditional | 06/04/2002SE |
| K020488 | Careside TrglycerideCDT · Traditional | 04/15/2002SE |
| K001462 | Careside HemoglobinKHG · Traditional | 08/21/2000SE |
| K993771 | Careside Direct BilirubinCIG · Traditional | 12/27/1999SE |
| K993634 | Careside AnalyzerJJF · Traditional | 12/02/1999SE |
| K992475 | Careside CO2, TotalKHS · Traditional | 09/15/1999SE |
| K991717 | Careside MGJGJ · Traditional | 08/10/1999SE |
| K991371 | Careside AmmoniaJID · Traditional | 08/03/1999SE |
Questions and answers
When was Careside Cholinesterase cleared by the FDA?
Careside Cholinesterase (K002792) received a 510(k) decision of Substantially Equivalent on November 8, 2000, 62 days after the submission was received.
What is the product code of K002792?
The FDA product code is DIH – Colorimetry, Cholinesterase, a Class I (low risk) device regulated under 21 CFR 862.3240.