| Device Type ID | 6017 |
| Device Name | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Regulation Description | Alcohol Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DIC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 6017 |
| Device | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Product Code | DIC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Alcohol Test System. |
| CFR Regulation Number | 862.3040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMMUNALYSIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 5 |
High Test Results | 5 |
Pump | 1 |
Probe | 1 |
Needle | 1 |
| Total Device Problems | 13 |