Teco CX3 Reagent Set for Synchron Cx System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060120 FDA 510(k)
- FDA Product Code
- CDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1770 FDA 510(k)
- Regulation Number
- 862.1770 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Teco Cx3 Reagent Set is a collection of chemical reagents used for the quantitative determination of BUN, calcium, creatinine, and glucose in human serum samples. It is classified as a urease and glutamic dehydrogenase urea nitrogen device.
This reagent set is designed for use on the Beckman CX3 System, where the reagents are loaded directly into the analyzer. The device has received FDA 510(k) clearance under K060120.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Teco Cx3 Reagent Set for Synchron Cx System, K060120 - Teco Cx3 Reagent Set for Synchron Cx System, Teco Cx3 Reagent Set for Synchron Cx System - Beudamed, TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060120 | Class II | Active |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA 510(k) K060120 24 fields · synced Sep 24, 2026