LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS— 510(k) K131652
Substantially EquivalentLin-Zhi International, Inc.
FDA 510(k) clearance K131652 for LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS, Substantially Equivalent on 2014-03-21. Applicant: Lin-Zhi International, Inc.. Device class: 2.
Clearance details
- Applicant
- Lin-Zhi International, Inc.
- Product code
- Code LAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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