Model 1020 Na+/K+(Sodium/Potassium)Analyzer Multi

Q: What is the product code of K844559?

The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.

FDA 510(k) K844559 · Thermo Orion

Substantially Equivalent

510(k) numberK844559

Submission

Device name: Model 1020 Na+/K+(Sodium/Potassium)Analyzer Multi
Applicant: Thermo Orion
Cambridge, MA, US
Received: November 21, 1984
Decision date: January 18, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: JGS – Electrode, Ion Specific, Sodium
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1665
Specialty: Clinical Chemistry

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K191365	Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional	Nova Biomedical Corporation	07/19/2019SE
K172232	LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional	Ams Diagnostics	06/12/2019SE
K183549	GEM Premier ChemSTATJGS · Traditional	Instrumentation Laboratory CO	02/16/2019SE

More from Instrumentation Laboratory CO

510(k)	Device	Decision
K023792	Calibration Pack, Models A9100-101S and A9100-103SJIX · Traditional	01/31/2003SE
K821822	Model 1020 Na/K AnalyzerCEM · Traditional	07/02/1982SE

Questions and answers

When was Model 1020 Na+/K+(Sodium/Potassium)Analyzer Multi cleared by the FDA?

Model 1020 Na+/K+(Sodium/Potassium)Analyzer Multi (K844559) received a 510(k) decision of Substantially Equivalent on January 18, 1985, 58 days after the submission was received.

What is the product code of K844559?

The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.