510(k) DEN170010
- Device
- LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
- Applicant
- Lin-Zhi International, Inc.
- 510(k) number
- DEN170010
- Product code
- QBK
- Decision
- Unknown (DENG)
- Decision date
- 2018-04-20
- Date received
- 2017-02-21
- Regulation
- 862.3590
- Classification name
- Meprobamate Test System
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Chris Wang
- Address
- 2945 Oakmead Village Ct. Santa Clara CA US 95051 95051
FDA Registration Numbers#
- 2020952
- 3005360469
- 3003610499
- 1827821
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QBK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | Immunalysis Corporation | 2019-11-15 |