Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
FDA product code DMT · Class II (moderate risk) · 21 CFR 862.3040 · Clinical Toxicology
8510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000410 | Synchron Systems Alcohol Reagent and CalibratorsDMT · Traditional | Beckman Coulter, Inc. | 04/10/2000SE |
| K971506 | Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol CalibratorDMT · Traditional | Beckman Instruments, Inc. | 06/03/1997SE |
| K934273 | Kodak Ektachem Clinical Chemistry Slide Alcohol (Alc)DMT · Traditional | Eastman Kodak Company | 03/21/1994SE |
| K923783 | Ethyl Alcohol AssayDMT · Traditional | Diagnostic Reagents, Inc. | 01/21/1993SE |
| K864894 | Easy-Test Alcohol (Alc), Item No. 67515/93DMT · Traditional | Em Diagnostic Systems, Inc. | 01/09/1987SE |
| K843378 | Ethyl Alcohol Assay KitDMT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 09/14/1984SE |
| K810467 | Emit-St Serum Ethyl Alcohol AssayDMT · Traditional | Syva Co. | 03/06/1981SE |
| K802621 | Emit-Stm Ethyl Alcohol AssayDMT · Traditional | Syva Co. | 10/31/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0295-2014 Class II | VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |