Product code DKC
- Device name
- Alcohol Control Materials
- Medical specialty
- Clinical Toxicology
- Device class
- 1
- Regulation number
- 862.3280
- 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 |
|---|---|---|---|
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | Medical Analysis Systems, Inc. | 2003-07-01 |
| K935819 | QUALITY CONTROL MATERIAL (ASSAYED) | Columbia Diagnostics, Inc. | 1994-03-22 |
| K933425 | AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 | Sigma Diagnostics, Inc. | 1993-11-16 |
| K934467 | BECKMAN CX AMMONIA/ALCOHOL CONTROL | Beckman-Diagnostic Systems Group | 1993-10-27 |
| K932067 | ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III | Sigma Diagnostics, Inc. | 1993-06-16 |
| K912827 | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | Cala Diagnostics | 1991-08-12 |
| K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | Cala Diagnostics | 1991-07-26 |
| K843872 | ETHANOL CONTROLS LOW & HIGH E5133/E5258 | Sigma Chemical Co. | 1984-10-31 |
| K833514 | TOXI CHEM SERUM ALCOHOL CONTROL | Fisher Diagnostics | 1983-12-08 |
| K810465 | EMIT-ST ETHYL ALCOHOL SERUM CONTROLS | Syva Co. | 1981-03-06 |
| K802618 | EMIT-STM ETHYL ALCOHOL URINE CONTROLS | Syva Co. | 1980-10-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811727017437 | Pointe Ethyl Alcohol Level 2 Control (300 mg/dL) | HORIBA INSTRUMENTS INCORPORATED | 2020-09-25 |
| 00811727017420 | Pointe Ethyl Alcohol Level 1 Control (50 mg/dL) | HORIBA INSTRUMENTS INCORPORATED | 2020-09-25 |
| 04250317535795 | Urine Control | Chromsystems Instruments + Chemicals GmbH | 2020-08-06 |
| 04250317535788 | Urine Control | Chromsystems Instruments + Chemicals GmbH | 2020-08-06 |
| 04250317535771 | Urine Control | Chromsystems Instruments + Chemicals GmbH | 2020-08-06 |
| 04250317544742 | Urine Control | Chromsystems Instruments + Chemicals GmbH | 2020-08-06 |
| 04250317546067 | Urine Control | Chromsystems Instruments + Chemicals GmbH | 2020-08-06 |
| 04250317546111 | Urine Control | Chromsystems Instruments + Chemicals GmbH | 2020-08-06 |
| 04250317502223 | Serum Control | Chromsystems Instruments + Chemicals GmbH | 2020-07-30 |
| 04250317502209 | Serum Control | Chromsystems Instruments + Chemicals GmbH | 2020-07-30 |
| 04250317544971 | Serum Control | Chromsystems Instruments + Chemicals GmbH | 2020-07-30 |
| 04250317545213 | Serum Control | Chromsystems Instruments + Chemicals GmbH | 2020-07-30 |
| 00884883001039 | DRI 300 mg/dL Alcohol Control | Microgenics Corporation | 2017-10-30 |
| 00884883001015 | DRI 50 mg/dL Alcohol Control | Microgenics Corporation | 2017-10-30 |
| 00840937110683 | Immunalysis | IMMUNALYSIS CORP | 2017-10-24 |
| 00840937110409 | Immunalysis | IMMUNALYSIS CORP | 2017-09-07 |
| 00817302021387 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021370 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021363 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021356 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021349 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021332 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 15099590222710 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590222727 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590222734 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| B07602240 | Ethyl Alcohol DAU Control, Level 1 Control | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| B07602250 | Ethyl Alcohol DAU Control, Level 2 Control | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| 00380740005511 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740005542 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740005535 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |