| Device Type ID | 6178 |
| Device Name | Gas Chromatography, Methamphetamine |
| Regulation Description | Methamphetamine 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 | 862.3610 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LAF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 6178 |
| Device | Gas Chromatography, Methamphetamine |
| Product Code | LAF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Methamphetamine Test System. |
| CFR Regulation Number | 862.3610 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMERICAN BIO MEDICA CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOPHOR DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HANMEDICS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEALGEN SCIENTIFIC LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMMUNALYSIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIN-ZHI INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |