Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
FDA 510(k) clearance K190397 · decided 2019-11-15
Clearance details
- K-number
- K190397
- Device name
- Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
- Applicant
- Immunalysis Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-02-19
- Decision date
- 2019-11-15
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- QBK
- Device class
- 2
- Regulation number
- 862.3590
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Pomona, 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 |
|---|---|---|
| LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay (DEN170010) | Lin-Zhi International, Inc. | 2018-04-20 |
Recalls involving this device
No recalls on record reference this clearance.