FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
K Number: K170416
·
Decision Jun 26, 2017
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
62
Applicant Total
50
Review Days
136
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Basic Information
- Device Name
- LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
- K Number
- K170416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3620
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lin-Zhi International, Inc.
- Date Received
- February 10, 2017
- Decision Date
- June 26, 2017
- Product Code
- DJR
- 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 |
|---|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | FDA class 2 | Clinical Toxicology |
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