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: GL1611 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: GL1611 FDA UDI
Primary DI / UDI-DI: 05055273203189 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

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Also classified as Glucose IVD, reagent.

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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

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Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI fd3bc038-c7b9-4f14-a4fb-ff8d18ffbb75 37 fields · synced May 30, 2026