Who else makes this device?

Name: ProLyte Electrolyte Analyzer
Brand: ProLyte Electrolyte Analyzer

Clinical Chemistry › Test SystemsElectrode, Ion Specific, Sodium

ProLyte Electrolyte Analyzer

The Prolyte® Electrolyte Analyzer is intended to measure sodium, potassium, chloride and lithium in whole blood, serum, plasma, and urine. Measurements obtained by this device are used to…

Registry build 21.09.26

The Prolyte® Electrolyte Analyzer is intended to measure sodium, potassium, chloride and lithium in whole blood, serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases involving electrolyte imbalance.

2manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code JGS
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 ProLyte Electrolyte Analyzer
Listed by	Diamond Diagnostics Inc., Hungary
FDA product code	JGS
Device type	Electrode, Ion Specific, Sodium
Device class	Class 2
Regulation	21 CFR 862.1665
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2023-06-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for ProLyte Electrolyte Analyzer
Catalogue number	Size	Status
0-DD-PROLYTE		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stat Profile	Nova Biomedical Corporation	13
i-STAT	Abbott Point OF Care Inc.	9
AU	Beckman Coulter, Inc.	8
GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2	Instrumentation Laboratory SPA	8
Nova	Nova Biomedical Corporation	6
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	5
Sodium Electrode	Roche Diagnostics Gmbh	4
Pointe Scientific, Inc.	Horiba Instruments Incorporated	3
Architect	Abbott Laboratories	3
Synermed®	Infrared Laboratory Systems LLC	3
Sodium Electrode	Diamond Diagnostics Inc.	3
Phoenix Diagnostics	Phoenix Diagnostics, Inc.	2

Showing 12 of 88. All products under Electrode, Ion Specific, Sodium

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K121140	2012-08-22
K102959	2011-01-14
K082462	2009-02-06
K070104	2008-05-07

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.