Who is the manufacturer of GLUCOSE (HEXOKINASE) KIT?

Randox Laboratories, Ltd. submitted the Traditional clearance for GLUCOSE (HEXOKINASE) KIT (K953210).

What is the FDA product code for GLUCOSE (HEXOKINASE) KIT?

CFR. It is classified under 21 CFR 862.1345 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for GLUCOSE (HEXOKINASE) KIT?

510(k) clearance (submission type: Traditional).

GLUCOSE (HEXOKINASE) KIT

K953210 · Randox Laboratories, Ltd. · CFR · Oct 25, 1996 · Clinical Chemistry

Device Facts

Record ID	K953210
Device Name	GLUCOSE (HEXOKINASE) KIT
Applicant	Randox Laboratories, Ltd.
Product Code	CFR · Clinical Chemistry
Decision Date	Oct 25, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1345
Device Class	Class 2

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.