Definition: A Meprobamate Test System Is A Device Intended To Measure Meprobamate In Human Specimens. Measurements Obtained By This Device Are Used To Detect The Presence Of Meprobamate To Diagnose The Use Or Overdose Of Meprobamate Or Structurally-related Drug
| Device Type ID | 6275 |
| Device Name | Meprobamate Test System |
| Physical State | Enzyme Immunoassay Reagent Kit |
| Technical Method | Enzyme Immunoassay |
| Target Area | Human Specimens, Urine |
| 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 | 862.3590 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6275 |
| Device | Meprobamate Test System |
| Product Code | QBK |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.3590 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LIN-ZHI INTERNATIONAL, INC. | ||
GRANTED | 1 | |