FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
K Number: K133710
·
Decision Feb 21, 2014
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
93
Applicant Total
50
Review Days
79
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Basic Information
- Device Name
- LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
- K Number
- K133710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lin-Zhi International, Inc.
- Date Received
- December 4, 2013
- Decision Date
- February 21, 2014
- Product Code
- DKB
- 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 |
|---|---|---|---|
| DKB | Calibrators, Drug Mixture | FDA class 2 | Clinical Toxicology |
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| K201223 | LZI Tramadol Enzyme Immunoassay | Jun 4, 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 |