The following data is part of a De Novo classification by Lin-zhi International, Inc. with the FDA for Lzi Carisoprodol Metabolite (meprobamate) Enzyme Immunoassay.
| DeNovo ID | DEN170010 |
| Device Name: | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay |
| Classification | Meprobamate Test System |
| Applicant | Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara, CA 95051 |
| Contact | Chris Wang |
| Product Code | QBK |
| CFR Regulation Number | 862.3590 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Toxicology |
| Classification Advisory | Toxicology |
| Type | Direct |
| Date Received | 2017-02-21 |
| Decision Date | 2018-04-20 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07603780 | DEN170010 | 000 |
| 00811727018397 | DEN170010 | 000 |
| B07603700 | DEN170010 | 000 |
| B07603710 | DEN170010 | 000 |
| B07603720 | DEN170010 | 000 |
| B07603730 | DEN170010 | 000 |
| B07603740 | DEN170010 | 000 |
| B07603750 | DEN170010 | 000 |
| B07603770 | DEN170010 | 000 |
| 00811727018380 | DEN170010 | 000 |