| Device Type ID | 6154 |
| Device Name | Enzyme Immunoassay, Benzodiazepine |
| Regulation Description | Benzodiazepine 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 | 862.3170 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JXM |
| 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 | 6154 |
| Device | Enzyme Immunoassay, Benzodiazepine |
| Product Code | JXM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Benzodiazepine Test System. |
| CFR Regulation Number | 862.3170 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HEALGEN SCIENTIFIC LLC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
IMMUNALYSIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PSYCHEMEDICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THERMO FISHER SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 8 |
High Test Results | 2 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ameditech Inc | III | Dec-24-2015 |
| 2 | Ameditech Inc | II | Nov-18-2015 |