Who else makes this device?

Name: K Electrode, ISE Module
Brand: K Electrode, ISE Module

Clinical Chemistry › Test SystemsElectrode, Ion Specific, Potassium

K Electrode, ISE Module

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…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code CEM
Manufacturer	City	Province	Registered as	Device types
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56

Record

Regulatory record for K Electrode, ISE Module
Listed by	Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
FDA product code	CEM
Device type	Electrode, Ion Specific, Potassium
Device class	Class 2
Regulation	21 CFR 862.1600
510(k)	K101741
Record published	2016-10-06
Record revised	2025-11-20 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 4 to 25 °C
Packaging	Box
Sizes	Height 60 mm; depth 40 mm; width 90 mm
Distribution end date	2025-11-19

Catalogue Numbers

Catalogue numbers for K Electrode, ISE Module
Catalogue number	Size	Status
K+ Electrode	Height 60 mm	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Nova	Nova Biomedical Corporation	8
Stat Profile	Nova Biomedical Corporation	7
Potassium electrode	Roche Diagnostics Gmbh	4
Potassium Electrode	Diamond Diagnostics Inc.	3
Synermed®	Infrared Laboratory Systems LLC	3
Architect	Abbott Laboratories	3
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	2
I.S.E. K	Randox Laboratories Limited	2
Pointe Scientific, Inc.	Horiba Instruments Incorporated	2
Potassium Electrode	Medica Corp.	2
Na/K Solution Pack	Medica Corp.	2
Selectra	VitalScientific B.V.	2

Showing 12 of 93. All products under Electrode, Ion Specific, Potassium

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.