FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LZI Tramadol Enzyme Immunoassay
K Number: K201223
·
Decision Jun 4, 2020
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
50
Review Days
29
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Basic Information
- Device Name
- LZI Tramadol Enzyme Immunoassay
- K Number
- K201223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lin-Zhi International, Inc.
- Date Received
- May 6, 2020
- Decision Date
- June 4, 2020
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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Other Clearances by Lin-Zhi International, Inc.
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|---|---|---|---|
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| K251634 | LZI Fentanyl III Enzyme Immunoassay | Jun 18, 2025 | Substantially Equivalent |
| K202007 | LZI Oxycodone III Enzyme Immunoassay | Sep 17, 2020 | Substantially Equivalent |
| K201938 | LZI Fentanyl II Enzyme Immunoassay | Aug 7, 2020 | Substantially Equivalent |
| K192299 | LZI Cotinine II Enzyme Immunoassay | Nov 21, 2019 | Substantially Equivalent |
| K192433 | LZI Methadone II Enzyme Immunoassay | Oct 4, 2019 | Substantially Equivalent |
| K181159 | LZI Fentanyl Enzyme Immunoassay | Dec 3, 2018 | Substantially Equivalent |
| DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | Apr 20, 2018 | Unknown |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | Jun 26, 2017 | Substantially Equivalent |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls | May 28, 2015 | Substantially Equivalent |