← Back to catalogue
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 - Barbiturate Enzyme Immunoassay, Ca. # 0140 (500 Tests Kit)
FDA 510(k)Class II (US FDA 510(k))
510(k) K032764
Identifiers
- 510(k) Number
- K032764 FDA 510(k)
- FDA Product Code
- DIS FDA 510(k)
- Models / Variants
- Barbiturate Enzyme Immunoassay, Ca. # 0140 (500 Tests Kit) FDA 510(k)Cat# 0141 (5000 Tests Kit) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3150 FDA 510(k)
- Regulation Number
- 862.3150 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 - Barbiturate Enzyme Immunoassay, Ca. # 0140 (500 Tests Kit) by Lin-Zhi International, Inc. — Class II — FDA_510K…
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 | K032764 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA 510(k) K032764 24 fields · synced Jun 18, 2026