FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K Number: K131652
·
Decision Mar 21, 2014
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
48
Applicant Total
50
Review Days
289
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Basic Information
- Device Name
- LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
- K Number
- K131652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lin-Zhi International, Inc.
- Date Received
- June 5, 2013
- Decision Date
- March 21, 2014
- Product Code
- LAF
- 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 |
|---|---|---|---|
| LAF | Gas Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
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