Who else makes this device?

Name: I.S.E. K
Brand: I.S.E. K

Clinical Chemistry › Test SystemsElectrode, Ion Specific, Potassium

I.S.E. K

2 catalogue numbers from D400-0012, listed by Randox Laboratories Limited, United Kingdom, under Electrode, Ion Specific, Potassium. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

2recalls on this code

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 I.S.E. K
Listed by	Randox Laboratories Limited, United Kingdom
FDA product code	CEM
Device type	Electrode, Ion Specific, Potassium
Device class	Class 2
Regulation	21 CFR 862.1600
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Record published	2016-09-26
Record revised	2025-05-12 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 25 °C

Catalogue Numbers

Catalogue numbers for I.S.E. K
Catalogue number	Size	Status
D400-0012		In distribution
D200-0015		In distribution

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
Pointe Scientific, Inc.	Horiba Instruments Incorporated	2
Potassium Electrode	Medica Corp.	2
Na/K Solution Pack	Medica Corp.	2
Selectra	VitalScientific B.V.	2
FlexLab	Inpeco SA	1

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K230890	2023-09-08
K052914	2006-03-31

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2023-09-06	Class II	Under Investigation by firm	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when inco	35 units
2021-04-28	Class II	Software design	An issue was identified where the software froze during processing of commands, which resulted in no results displayed.	50 kits	2021-12-03

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.