Synermed Ise Reagents

Q: What is the product code of K940194?

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) K940194 · Synermed, Inc.

Substantially Equivalent

510(k) numberK940194

Submission

Device name: Synermed Ise Reagents
Applicant: Synermed, Inc.
Quebec, Canada, CA
Received: January 13, 1994
Decision date: April 5, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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

Other 510(k)s with product code JGS

510(k)	Device	Applicant	Decision
K252475	ABL90 FLEX PLUS SystemJGS · Traditional	Radiometer Medicals Aps	05/01/2026SE
K230275	i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional	Abbott Point of Care, Inc.	10/27/2023SE
K222438	A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional	Siemens Healthcare Diagnostics, Inc.	07/25/2023SE
K220977	ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional	Beckman Coulter Laboratory Systems (Suzhou) Co.…	07/20/2023SE
K213486	GLP systems TrackJGS · Traditional	Abbott Laboratories	03/10/2022SE
K200403	Stat Profile Prime Plus Analyzer SystemJGS · Traditional	Nova Biomedical Corporation	04/14/2020SE
K183688	i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional	Abbott Point of Care, Inc.	02/07/2020SE
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
K973109	Synermed Near-Infrared Direct Bilirubin Reagent KitCIG · Traditional	09/25/1997SE
K972716	Synermed Total Bilirubin Reagent KitCIG · Traditional	08/07/1997SE
K971491	Synermed Ir 200 Chemistry AnalyzerJJF · Traditional	06/26/1997SE
K962479	Synermed Ise ReagentsCGZ · Traditional	03/03/1997SE
K963939	Synermed Direct Bilirubin Reagent KitCIG · Traditional	12/18/1996SE
K960793	Synermed Enzymatic CO2 Reagent KitKHS · Traditional	03/11/1996SE
K953395	Synermed Calcium Reagent KitCJY · Traditional	08/31/1995SE
K952179	Synermed Ise ReagentsJGS · Traditional	06/20/1995SE
K943924	Creatinine-Po Reagent KitCGX · Traditional	09/20/1994SE
K941091	Synermed Amylase Reagent KitJFJ · Traditional	05/03/1994SE

Questions and answers

When was Synermed Ise Reagents cleared by the FDA?

Synermed Ise Reagents (K940194) received a 510(k) decision of Substantially Equivalent on April 5, 1994, 82 days after the submission was received.

What is the product code of K940194?

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