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Lzi Amphetamines 500 Homogenous Enzyme Immunoassay +2 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K102210
Identifiers
- 510(k) Number
- K102210 FDA 510(k)
- FDA Product Code
- DKZ FDA 510(k)
- Models / Variants
- Lzi Amphetamines 500 Calibrators FDA 510(k)Lzi Amphetamines 500 Controls FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3100 FDA 510(k)
- Regulation Number
- 862.3100 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Lzi Amphetamines 500 Homogenous Enzyme Immunoassay +2 more models by Lin-Zhi International, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102210 | Class II | Active |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA 510(k) K102210 24 fields · synced Jun 18, 2026