Product code DNN
- Device name
- Calibrators, Ethyl Alcohol
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3200
- 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 |
|---|---|---|---|
| K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | 1999-03-31 |
| K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | 1997-10-01 |
| K924733 | ETHYL ALCOHOL CALIBRATORS & CONTROL | Diagnostic Reagents, Inc. | 1992-12-09 |
| K882117 | ETHYL ALCOHOL STANDARD | Verichem Laboratories, Inc. | 1988-08-04 |
| K853532 | ALCOHOL CALIBRATORS | Diagnostic Systems | 1985-09-16 |
| K810466 | ETHYL ALCOHOL SERUM CALIBRATOR | Syva Co. | 1981-03-06 |
| K802620 | EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR | Syva Co. | 1980-10-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811727017413 | Pointe Ethyl Alcohol Calibrator (100 mg/dL) | HORIBA INSTRUMENTS INCORPORATED | 2020-09-25 |
| 04250317536754 | Urine Calibrator Set | Chromsystems Instruments + Chemicals GmbH | 2019-03-22 |
| 00380740135355 | Alinity | ABBOTT LABORATORIES | 2018-07-11 |
| 00852553007247 | Ethanol Standard Kit | VERICHEM LABORATORIES, INC. | 2018-01-16 |
| 00852553007346 | Ethanol Standard, Level D | VERICHEM LABORATORIES, INC. | 2018-01-16 |
| 00884883005129 | DRI Negative Alcohol Calibrator | Microgenics Corporation | 2016-09-12 |
| 00884883005198 | DRI 100 mg/dL Alcohol Calibrator | Microgenics Corporation | 2016-09-12 |
| 00884883011540 | DRI 100 mg/dL Alcohol Calibrator | Microgenics Corporation | 2016-09-12 |
| 00884883011564 | DRI Negative Alcohol Calibrator | Microgenics Corporation | 2016-09-12 |
| 00817302021356 | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 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 |
| 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 |
| 00811727010087 | POINTE SCIENTIFIC Alcohol Standard | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 15099590222079 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 10758750005048 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |
| B07602230 | Ethyl Alcohol DAU Calibrator, Calibrator #2 | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| 00380740005511 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740005535 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740005542 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740005528 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |