DEN170010 is an FDA 510(k) submission for the LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay. This device is classified as a Meprobamate Test System (Class II - Special Controls, product code QBK).
Submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Not Cleared (DENG) decision on April 20, 2018.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3590. 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 Compounds (e.g., Prodrugs)..
| 510(k) Number | DEN170010 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 21, 2017 |
| Decision Date | April 20, 2018 |
| Days to Decision | 423 days |
| Submission Type | Direct |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | QBK — Meprobamate Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3590 |
| 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 Compounds (e.g., Prodrugs). |