FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
K Number: DEN170010
·
Decision Apr 20, 2018
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
50
Review Days
423
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Basic Information
- Device Name
- LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
- K Number
- DEN170010
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 862.3590
- Medical Specialty
- Clinical Toxicology
- Decision
- Unknown
- Applicant
- Lin-Zhi International, Inc.
- Date Received
- February 21, 2017
- Decision Date
- April 20, 2018
- Product Code
- QBK
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QBK | Meprobamate Test System | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QBK), ordered by most recent decision date.
View allOther Clearances by Lin-Zhi International, Inc.
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