Gluc-Hk

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: GLUC-HK FDA UDI
Generic Name: Glucose IVD, reagent FDA UDI
Device Name: A Glucose test system is a device intended for the quantitative in vitro determination of glucose concentration in serum, plasma and urine FDA UDI
Model / Reference: GL2822 FDA UDI
Description: A Glucose test system is a device intended for the quantitative in vitro determination of glucose concentration in serum, plasma and urine FDA UDI

Identifiers

Catalog Number: GL2822 FDA UDI
Primary DI / UDI-DI: 05055273203219 FDA UDI
510(k) Number: K953210 FDA UDI
FDA Product Code: CFR FDA UDI
GMDN Term: Glucose IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose IVD, reagent

Gluc-Hk by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose IVD, reagent.

Glucose Tolerance Beverage — AZER SCIENTIFIC INCORPORATED · Class II
Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
Glucose Tolerance Beverage — AZER SCIENTIFIC INCORPORATED · Class II
Piccolo Basic Metabolic Panel — ABAXIS, INC. · Class II
Vive Precision — VIVE HEALTH LLC · Class II
GoChek2 — Microtech Medical (Hangzhou) Co., Ltd. · Class II
ENZYMATIC GLUCOSE — STERLING DIAGNOSTICS INC
GoChek2 — Microtech Medical (Hangzhou) Co., Ltd. · Class II

Cleared under the same submission

K953210 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI 85b2ee77-e2aa-4314-840d-235a70b3058b 37 fields · synced Jun 8, 2026