Flucose U.V. Test Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K770844 ↗

FDA Product Code

CFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Foam Nose

  Class I

  FDA 510(k) K840399 Active Cleared 16 Mar 1984

• Isotonic Diluent

  Class I

  FDA 510(k) K781008 Active Cleared 28 Jun 1978

• Hi-Lo Temp Thermocouple to Thermister Adaptor

  Class II

  FDA 510(k) K844201 Active Cleared 4 Mar 1985

• Glucose Reagent (O-Toluidine)

  Class II

  FDA 510(k) K771314 Active Cleared 3 Aug 1977

• Ria Quant C-Peptide Kit

  Class I

  FDA 510(k) K812689 Active Cleared 6 Oct 1981

• Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

  Class II

  FDA 510(k) K874568 Active Cleared 6 Jan 1988

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• What is the Flucose UV Test Kit used for?

  The Flucose UV Test Kit is designed for the quantitative measurement of glucose levels in blood or serum samples. It employs a hexokinase-based enzymatic reaction detected via ultraviolet (UV) spectrophotometry, enabling precise clinical chemistry analysis. This method is particularly useful in laboratory settings where accurate glucose monitoring is critical for diagnostic assessments.

• How is the Flucose UV Test Kit supplied, and is it sterile?

  The Flucose UV Test Kit is supplied as a single-use, non-sterile diagnostic reagent system. It is intended for use in clinical chemistry laboratories and requires compatibility with standard UV spectrophotometers. The non-sterile designation means it is not intended for direct patient use without further preparation or processing in a controlled lab environment.

• Is the Flucose UV Test Kit intended for reuse, or is it disposable?

  The Flucose UV Test Kit is explicitly designed for single-use only. Each kit is meant to be used once per test, ensuring accuracy and preventing cross-contamination. Reuse is not recommended or supported by the manufacturer, as it could compromise the integrity of the results or the sterility of subsequent tests.

• What storage conditions should be followed for the Flucose UV Test Kit?

  While specific storage conditions are not detailed in the regulatory data, UV-based test kits like the Flucose UV Test Kit generally require protection from light and moisture to maintain reagent stability. Storing the kit in a cool, dry place, away from direct sunlight or humidity, is advisable to preserve its performance and accuracy for clinical use.

• What regulatory pathway does the Flucose UV Test Kit follow?

  The Flucose UV Test Kit holds an FDA 510(k) clearance under the Traditional pathway, with the clearance number K770844. This classification falls under CFR 862.1345 for Class II chemistry devices, indicating it has been deemed substantially equivalent to a predicate device. No third-party certification is noted in the available data.