Modify Electrolyte Analyzer Model SERA-210

Q: What is the product code of K844806?

The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.

FDA 510(k) K844806 · Horiba Instruments, Inc.

Substantially Equivalent

510(k) numberK844806

Submission

Device name: Modify Electrolyte Analyzer Model SERA-210
Applicant: Horiba Instruments, Inc.
Irvine, CA, US
Received: December 11, 1984
Decision date: January 8, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: CEM – Electrode, Ion Specific, Potassium
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1600
Specialty: Clinical Chemistry

Other 510(k)s with product code CEM

510(k)	Device	Applicant	Decision
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K241037	ABL90 FLEX PLUS SystemCEM · Traditional	Radiometer Medicals Aps	01/14/2025SE
K220396	EasyStat 300CEM · Traditional	Medica Corporation	09/26/2023SE
K230890	ISE ElectrodesCEM · Special	Randox Laboratories, Ltd.	09/08/2023SE
K200544	SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+CEM · Traditional	Diamond Diagnostics, Inc.	10/01/2020SE
K121012	Flexlab 3.6, Accelerator A3600CEM · Traditional	Inpeco S.P.A.	08/31/2012SE
K121040	Smartlyte Electrolyte AnalyzerCEM · Traditional	Diamond Diagnostics, Inc.	08/30/2012SE
K112995	Gem Premier 4000CEM · Traditional	Instrumentation Laboratory CO	05/03/2012SE
K110520	Biolis 12ICEM · Traditional	Tokyo Boeki Medisys, Inc.	03/23/2012SE
K112412	AU5800(R) Chemistry AnalyzerCEM · Traditional	Beckman Coulter, Inc.	12/23/2011SE

More from Beckman Coulter, Inc.

510(k)	Device	Decision
K853405	Electrolyte Analyzer SERA-252CHL · Traditional	12/04/1985SE
K853356	SERA-210 Electrolyte AnalyzerCEM · Traditional	09/03/1985SE
K841424	Electrolyte Analyzer SERA-210JGS · Traditional	06/22/1984SE
K841441	SERA-250 · Traditional	04/06/1984SESP

Questions and answers

When was Modify Electrolyte Analyzer Model SERA-210 cleared by the FDA?

Modify Electrolyte Analyzer Model SERA-210 (K844806) received a 510(k) decision of Substantially Equivalent on January 8, 1985, 28 days after the submission was received.

What is the product code of K844806?

The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.