Colorimetry, Cholinesterase
FDA product code DIH · Class I (low risk) · 21 CFR 862.3240 · Clinical Toxicology
26510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Sclavo, Inc. 3
- Sigma Diagnostics, Inc. 2
- Eastman Kodak Company 2
- Tech Intl. Co. 1
- Beckman Coulter Inc. 1
- SENTINEL CH. SpA 1
- Olympus America, Inc. 1
- Wiener Laboratories Saic 1
- Bayer Diagnostics Corp. 1
- Careside, Inc. 1
- Bayer Corp. 1
- Eqm Research, Inc. 1
- Instrumentation Laboratory CO 1
- Diagnostic Chemicals , Ltd. 1
- Gilford Diagnostics 1
- Crestat Diagnostics, Inc. 1
- Beckman 1
- Sigma Chemical Co. 1
- E.I. Dupont DE Nemours & Co., Inc. 1
- J. D. Assoc. 1
510(k) clearances
| 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 |
| K955498 | Cholinesterase Assay Kit, Catalogue# 300-05DIH · Traditional | Diagnostic Chemicals , Ltd. | 01/24/1996SE |
| K914171 | In Vitro Diagnostic Regeant Set,CholinesteraseDIH · Traditional | Tech Intl. Co. | 12/18/1991SE |
| K913198 | Kodak Ektachem DT Slides (Che)DIH · Traditional | Eastman Kodak Company | 08/26/1991SE |
| K912148 | Cholinesterase Test KitDIH · Traditional | Crestat Diagnostics, Inc. | 08/12/1991SE |
| K912217 | Kodak Ektachem Clinical Chemistry SlidesDIH · Traditional | Eastman Kodak Company | 07/01/1991SE |
| K893583 | Beckman Cholinesterase Reagent KitDIH · Traditional | Beckman | 08/15/1989SE |
| K885272 | Cholinesterase Reagent, Dibucaine & FluorideDIH · Traditional | Sigma Chemical Co. | 03/28/1989SE |
| K880199 | Cholinesterase - Acetythiocholine SubstrateDIH · Traditional | Sclavo, Inc. | 01/27/1989SE |
| K880049 | Cholinesterase - Butyrythiocholine SubstrateDIH · Traditional | Sclavo, Inc. | 01/27/1989SE |
| K873496 | Atypical CholinesteraseDIH · Traditional | Sclavo, Inc. | 01/27/1989SE |
| K883890 | Du Pont Dimension Pseudocholinesterase MethodDIH · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/29/1988SE |
| K863203 | Cholinesterase (BTC) ReagentDIH · Traditional | Sigma Diagnostics, Inc. | 09/17/1986SE |
| K863202 | Cholinesterase (PTC) ReagentDIH · Traditional | Sigma Diagnostics, Inc. | 09/16/1986SE |
| K863111 | CholinesteraseDIH · Traditional | J. D. Assoc. | 09/11/1986SE |
| K862168 | Raichem Cholinesterase ReagentDIH · Traditional | Reagents Applications, Inc. | 06/27/1986SE |
| K791725 | Cholinesterase ReagentDIH · Traditional | Gilford Diagnostics | 10/17/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2123-2025 Class II | VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides)…Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of… | Ortho-Clinical Diagnostics, Inc. | 06/10/2025Open, Classified |
| Z-2122-2025 Class II | VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2)…Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of… | Ortho-Clinical Diagnostics, Inc. | 06/10/2025Open, Classified |
| Z-2121-2025 Class II | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products…Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of… | Ortho-Clinical Diagnostics, Inc. | 06/10/2025Open, Classified |
| Z-2120-2025 Class II | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products…Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of… | Ortho-Clinical Diagnostics, Inc. | 06/10/2025Open, Classified |
| Z-0303-2014 Class II | VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |