Calibrators, Ethyl Alcohol
FDA product code DNN · Class II (moderate risk) · 21 CFR 862.3200 · Clinical Toxicology
7510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990516 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | Emd Chemicals, Inc. | 03/31/1999SE |
| K973054 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | Emd Chemicals, Inc. | 10/01/1997SE |
| K924733 | Ethyl Alcohol Calibrators & ControlDNN · Traditional | Diagnostic Reagents, Inc. | 12/09/1992SE |
| K882117 | Ethyl Alcohol StandardDNN · Traditional | Verichem Laboratories, Inc. | 08/04/1988SE |
| K853532 | Alcohol CalibratorsDNN · Traditional | Diagnostic Systems | 09/16/1985SE |
| K810466 | Ethyl Alcohol Serum CalibratorDNN · Traditional | Syva Co. | 03/06/1981SE |
| K802620 | Emit-Stm Ethyl Alcohol Urine CalibratorDNN · Traditional | Syva Co. | 10/31/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0126-2011 | EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This… | Hospira, Inc. | 07/26/2010Terminated |
| Z-1607-2008 | EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10…Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml… | EMD Chemicals Inc | 03/27/2008Terminated |