Sentech's Ulab 1000 Clinical Chem.

Q: What is the product code of K841575?

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) K841575 · Sen Tech Medical Corp.

Substantially Equivalent

510(k) numberK841575

Submission

Device name: Sentech's Ulab 1000 Clinical Chem.
Applicant: Sen Tech Medical Corp.
Mchenry, IL, US
Received: April 17, 1984
Decision date: July 6, 1984
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
K253491	ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional	Roche Diagnostics	02/12/2026SE
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
K910071	Porta Gas Compressed Gas Cylinder CartGET · Traditional	03/22/1991SE
K855091	Chem-Pro 1000 Clinical Chemistry-Analysis SysCDS · Traditional	03/14/1986SE
K854260	Chempro 1000CGA · Traditional	11/19/1985SE
K851100	Chem Pro 1000 Chemistry AnalysisCEM · Traditional	07/09/1985SE

Questions and answers

When was Sentech's Ulab 1000 Clinical Chem. cleared by the FDA?

Sentech's Ulab 1000 Clinical Chem. (K841575) received a 510(k) decision of Substantially Equivalent on July 6, 1984, 80 days after the submission was received.

What is the product code of K841575?

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