Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
FDA product code DML · Class II (moderate risk) · 21 CFR 862.3040 · Clinical Toxicology
13510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013538 | EthanolDML · Traditional | Abbott Laboratories | 12/14/2001SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | Syva Co. | 02/01/2000SE |
| K963197 | On.Site AlcoholDML · Traditional | Ansys, Inc. | 09/19/1996SE |
| K953765 | Axsym Rea EthanolDML · Traditional | Abbott Laboratories | 09/27/1995SE |
| K952839 | Boehringer Mannheim Ethyl Alcohol AssayDML · Traditional | Boehringer Mannheim Corp. | 08/24/1995SE |
| K923337 | On*Site AlcoholDML · Traditional | Toxi-Lab, Inc. | 01/12/1993SE |
| K914777 | Sigma Procedure No. 333-UVDML · Traditional | Sigma Diagnostics, Inc. | 12/27/1991SE |
| K874382 | Raichem(Tm) Alcohol ReagentDML · Traditional | Reagents Applications, Inc. | 01/11/1988SE |
| K872180 | Kinetic 610 EthanolDML · Traditional | American Monitor Corp. | 07/07/1987SE |
| K863419 | Emds(Tm) Alcohol Testpacks, #67691/95DML · Traditional | Em Diagnostic Systems, Inc. | 09/29/1986SE |
| K840769 | Paramax Alcohol ReagentDML · Traditional | American Dade | 04/13/1984SE |
| K840400 | Emit ST Serum Ethyl Alcohol AssayDML · Traditional | Syva Co. | 03/23/1984SE |
| K840171 | Emit ST Urine Ethyl Alcohol AssayDML · Traditional | Syva Co. | 03/19/1984SE |