LZI Cotinine II Enzyme Immunoassay— 510(k) K192299
Substantially EquivalentLin-Zhi International, Inc.
FDA 510(k) clearance K192299 for LZI Cotinine II Enzyme Immunoassay, Substantially Equivalent on 2019-11-21. Applicant: Lin-Zhi International, Inc.. Device class: 1.
Clearance details
- Applicant
- Lin-Zhi International, Inc.
- Product code
- Code MKU
- Device class
- Class 1
- Regulation
- 21 CFR 862.3220
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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