K Electrode, Ise Module

FDA UDI

Class II (US FDA UDI)

by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Identity

Trade Name: K ELECTRODE, ISE MODULE FDA UDI
Generic Name: Potassium (K+) electrode IVD FDA UDI
Device Name: Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. FDA UDI
Model / Reference: K+ Electrode FDA UDI
Description: Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. FDA UDI

Identifiers

Catalog Number: 5202 FDA UDI
Primary DI / UDI-DI: 05999883586693 FDA UDI
510(k) Number: K101741 FDA UDI
FDA Product Code: CEM FDA UDI
GMDN Term: Potassium (K+) electrode IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1600 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Dimensions & Sizes

Size: Height — 60 Millimeter FDA UDI
Depth — 40 Millimeter FDA UDI
Width — 90 Millimeter FDA UDI

Category: Potassium (K+) electrode IVD

K Electrode, Ise Module by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag — Class II — FDA…

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Also classified as Potassium (K+) electrode IVD.

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Ready Sensor™ GOLD Potassium Sensor — Siemens Healthcare Diagnostics · Class II
Alfa Wassermann — Alfa Wassermann, Inc. · Class II
i-STAT — Abbott Point of Care Inc. · Class II
RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor — Siemens Healthcare Diagnostics · Class II
ISE Potassium Electrode — STANBIO LABORATORY, L.P. · Class II

Cleared under the same submission

K101741 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: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Sources (1)

FDA UDI c9ef5ee3-6062-4ded-9369-5d0014614655 38 fields · synced Jun 8, 2026