LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
FDA 510(k) clearance DEN170010 · decided 2018-04-20
Clearance details
- K-number
- DEN170010
- Device name
- LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
- Applicant
- Lin-Zhi International, Inc.
- Decision
- Unknown
- Date received
- 2017-02-21
- Decision date
- 2018-04-20
- Days to decision
- 423 days
- Clearance type
- Direct
- Product code
- QBK
- Device class
- 2
- Regulation number
- 862.3590
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (K190397) | Immunalysis Corporation | 2019-11-15 |
Recalls involving this device
No recalls on record reference this clearance.