Who is the manufacturer of HEMOCUE B-GLCOSE SYSTEM?

Hemocue, Inc. submitted the Traditional clearance for HEMOCUE B-GLCOSE SYSTEM (K962415).

What is the FDA product code for HEMOCUE B-GLCOSE SYSTEM?

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

What is the regulatory pathway for HEMOCUE B-GLCOSE SYSTEM?

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

HEMOCUE B-GLCOSE SYSTEM

K962415 · Hemocue, Inc. · LFR · Oct 15, 1996 · Clinical Chemistry

Device Facts

Record ID	K962415
Device Name	HEMOCUE B-GLCOSE SYSTEM
Applicant	Hemocue, Inc.
Product Code	LFR · Clinical Chemistry
Decision Date	Oct 15, 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.