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Liquid Glucose (Hexokinase) Reagent Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K971754

by Pointe Scientific, Inc.

Identifiers

510(k) Number
K971754 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 Liquid Glucose (Hexokinase) Reagent Set is a device used for the in vitro quantitative measurement of glucose in serum. It operates based on the hexokinase method, where the formation of NADH causes an increase in absorbance at 340 nm, which is directly proportional to the glucose concentration in the sample.

This reagent set is supplied as a liquid formulation, available in configurations such as 1 x 120 mL. It is intended for use in clinical chemistry laboratories. It is classified as a Class II device under FDA regulation number 862.1345 and received 510(k) clearance (K971754) on July 22, 1997, as substantially equivalent to a predicate device.

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: Pointe Scientific Glucose (Hexokinase) Liquid Reagents, Glucose Hexokinase Reagent Set, Pointe Scientific - VWR, Glucose Hexokinase Reagent G7517-120, 1 x 120 mL (5390012910) | HORIBA ..., LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K971754) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pointe Scientific, Inc.
FDA Applicant
Pointe Scientific, Inc.,

Sources (1)

  • FDA 510(k) K971754 24 fields · synced Sep 24, 2026