Product code DIH
- Device name
- Colorimetry, Cholinesterase
- Medical specialty
- Clinical Toxicology
- Device class
- 1
- Regulation number
- 862.3240
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K103373 | SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 | Beckman Coulter, Inc. | 2011-02-07 |
| K061093 | CHOLINESTERASE GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | 2006-07-03 |
| K051444 | SENTINEL CHOLINESTERASE LIQUID | Sentinel Ch. Srl | 2005-06-20 |
| K030045 | OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) | Olympus America, Inc. | 2003-02-21 |
| K023992 | WIENER LAB COLINESTERASA AA | Wiener Laboratories Saic | 2003-02-12 |
| K013750 | ADVIA 1650 CHOLINESTERASE ASSAY | Bayer Diagnostics Corp. | 2002-01-18 |
| K002792 | CARESIDE CHOLINESTERASE | Careside, Inc. | 2000-11-08 |
| K001344 | ADVIA IMS | Bayer Corp. | 2000-06-26 |
| K961656 | TEST-MATE CHE CHOLINESTERASE TEST SYSTEM | Eqm Research, Inc. | 1996-11-26 |
| K943367 | IL TEST CHOLINESTERASE | Instrumentation Laboratory CO | 1996-02-05 |
| K955498 | CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 | Diagnostic Chemicals , Ltd. | 1996-01-24 |
| K914171 | IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE | Tech Intl. Co. | 1991-12-18 |
| K913198 | KODAK EKTACHEM DT SLIDES (CHE) | Eastman Kodak Company | 1991-08-26 |
| K912148 | CHOLINESTERASE TEST KIT | Crestat Diagnostics, Inc. | 1991-08-12 |
| K912217 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | 1991-07-01 |
| K893583 | BECKMAN CHOLINESTERASE REAGENT KIT | Beckman | 1989-08-15 |
| K885272 | CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE | Sigma Chemical Co. | 1989-03-28 |
| K873496 | ATYPICAL CHOLINESTERASE | Sclavo, Inc. | 1989-01-27 |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | Sclavo, Inc. | 1989-01-27 |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | Sclavo, Inc. | 1989-01-27 |
| K883890 | DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1988-11-29 |
| K863203 | CHOLINESTERASE (BTC) REAGENT | Sigma Diagnostics, Inc. | 1986-09-17 |
| K863202 | CHOLINESTERASE (PTC) REAGENT | Sigma Diagnostics, Inc. | 1986-09-16 |
| K863111 | CHOLINESTERASE | J. D. Assoc. | 1986-09-11 |
| K862168 | RAICHEM CHOLINESTERASE REAGENT | Reagents Applications, Inc. | 1986-06-27 |
| K791725 | CHOLINESTERASE REAGENT | Gilford Diagnostics | 1979-10-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860010612200 | Test-mate ChE Cholinesterase Test System | Eqm Research, Inc. | 2023-07-31 |
| 00860010612217 | AChE Assay Kit | Eqm Research, Inc. | 2023-07-31 |
| 00860010612224 | PChE Assay Kit | Eqm Research, Inc. | 2023-07-31 |
| 10673486001488 | Teco Diagnostics Cholinesterase Reagent Set | TECO DIAGNOSTICS | 2023-07-26 |
| 06971674862963 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674863052 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674863045 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674863038 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674863021 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674863014 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674863007 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674862994 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674862987 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674862970 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674862956 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674862949 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674862932 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 00630414611044 | Atellica CH Cholinesterase_2 | Siemens Healthcare Diagnostics Inc. | 2023-06-29 |
| 00630414305042 | Atellica CH Cholinesterase_2 | Siemens Healthcare Diagnostics Inc. | 2023-06-29 |
| 08800055732985 | ARENA Star | ARUM DENTISTRY Co., Ltd. | 2023-03-31 |
| 04015630991549 | Cholinesterase | Roche Diagnostics GmbH | 2021-06-28 |
| 04015630920945 | Cholinesterase Gen.2 | Roche Diagnostics GmbH | 2021-01-18 |
| 00842768014178 | Dimension® Flex® reagent cartridge PCHE | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768015373 | Dimension Vista® Flex® reagent cartridge PCHE | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414596273 | Atellica CH CHE | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414510149 | ADVIA® Chemistry CHE Cholinesterase Reagents | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414465401 | ADVIA® Chemistry CHE Cholinesterase Reagents | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 10758750000241 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-04-18 |
| 10758750004225 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-04-18 |
| 07613336133620 | Cholinesterase Gen.2 | Roche Diagnostics GmbH | 2020-03-05 |