Who else makes this device?

Name: MR Na/K Check Solution
Brand: MR Na/K Check Solution

Clinical Chemistry › Test SystemsElectrode, Ion Specific, Potassium

MR Na/K Check Solution

Catalogue number 105-011386-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, 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

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 MR Na/K Check Solution
Listed by	Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China
FDA product code	CEM
Device type	Electrode, Ion Specific, Potassium
Device class	Class 2
Regulation	21 CFR 862.1600
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K160370
Record published	2026-01-23

Specifications

Specifications
MRI safety	MR Unsafe
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for MR Na/K Check Solution
Catalogue number	Size	Status
105-011386-00		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
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

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of MR Na/K Check Solution
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Mindray DS USA, Inc.	510(k) number	2019-12-09	Class II	Nonconforming Material/Component	The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.	7	2020-09-17
Mindray DS USA, Inc.	510(k) number	2019-12-09	Class II	Nonconforming Material/Component	The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.	6	2020-09-17

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.