Identifiers
- 510(k) Number
- K041052 FDA 510(k)
- FDA Product Code
- CFR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Raichem Glucose UV Liquid is an enzymatic reagent system designed for the quantitative determination of glucose levels in human serum or plasma. It functions as an in vitro diagnostic device used to measure glucose concentrations within these clinical samples.
This device is intended for professional in vitro diagnostic use. It has received FDA 510(k) clearance under the regulation number 862.1345 for use in clinical chemistry settings.
Frequently asked questions
What is the primary function of the Raichem Glucose UV Liquid?
This device is an enzymatic reagent system used for the quantitative determination of glucose concentrations. It is specifically designed for use with human serum or plasma samples in clinical chemistry settings.
Who is the intended user for this diagnostic reagent?
The Raichem Glucose UV Liquid is intended exclusively for professional in vitro diagnostic use. It is designed to be utilized by trained laboratory personnel within a clinical chemistry environment.
What is the regulatory status of this device?
The Raichem Glucose UV Liquid has received FDA 510(k) clearance under regulation number 862.1345. This indicates that the device has been reviewed and cleared for use in clinical chemistry applications.
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: RAICHEM GLUCOSE UV (LIQUID) (K041052) — FDA 510(k) | Innolitics, RAICHEM GLUCOSE UV (LIQUID) by HEMAGEN DIAGNOSTICS, INC. | FDA 510(k ..., K012668 - RAICHEM GLUCOSE UV REAGENT | FDA 510 (k), RAICHEM GLUCOSE UV (LIQUID) 510(k) K041052 - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041052 | Class II | Active |
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Manufacturer
- Manufacturer
- Hemagen Diagnostics, Inc.
Sources (1)
- FDA 510(k) K041052 24 fields · synced Sep 23, 2026