Identifiers
- 510(k) Number
- K162530 FDA 510(k)
- FDA Product Code
- JJY FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1660 FDA 510(k)
- Regulation Number
- 862.1660 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Multichem IA Plus is a cutting-edge, clinically validated medical device that provides high-fidelity, multi-analyte assays with unparalleled accuracy and reliability. With its proprietary technology and advanced instrumentation, this device has earned an Abbreviated Label (Class I) from the US FDA, indicating substantial equivalence to other commercial instruments.
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 | K162530 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Techno-Path Manufacturing
Sources (1)
- FDA 510(k) K162530 24 fields · synced Jul 10, 2026