Vitros Chemistry Products K+Dt Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+Dt Slides: 153 2258

Q: What is the product code of K083680?

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) K083680 · Ortho-Clinical Diagnostics, Inc.

Substantially Equivalent

510(k) numberK083680

Submission

Device name: Vitros Chemistry Products K+Dt Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+Dt Slides: 153 2258
Applicant: Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US
Received: December 12, 2008
Decision date: February 27, 2009
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

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

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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

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Questions and answers

When was Vitros Chemistry Products K+Dt Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+Dt Slides: 153 2258 cleared by the FDA?

Vitros Chemistry Products K+Dt Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+Dt Slides: 153 2258 (K083680) received a 510(k) decision of Substantially Equivalent on February 27, 2009, 77 days after the submission was received.

What is the product code of K083680?

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