Vitros Chemistry Products Crea DT Slides; Vitros Chemistry Products DT Calibrator Kit

Q: What is the product code of K001769?

The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.

FDA 510(k) K001769 · Ortho-Clinical Diagnostics

Substantially Equivalent

510(k) numberK001769

Submission

Device name: Vitros Chemistry Products Crea DT Slides; Vitros Chemistry Products DT Calibrator Kit
Applicant: Ortho-Clinical Diagnostics
Rochester, NY, US
Received: June 12, 2000
Decision date: June 21, 2000
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: CGX – Alkaline Picrate, Colorimetry, Creatinine
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1225
Specialty: Clinical Chemistry

Other 510(k)s with product code CGX

510(k)	Device	Applicant	Decision
K252206	Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track	Nova Biomedical Corporation	01/09/2026SE
K251058	Tru Kidney Health Test Panel; Tru AnalyzerCGX · Traditional	Truvian Health	11/26/2025SE
K242685	Atellica® CH Creatinine_3 (Crea3)CGX · Traditional	Siemens Healthcare Diagnostics, Inc.	12/04/2024SE
K221813	Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track	Nova Biomedical Corporation	11/19/2024SE
K210452	Creatinine2CGX · Traditional	Abbott Ireland Diagnostics Division	03/22/2022SE
K161494	Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX · Traditional	Siemens Healthcare Diagnostics, Inc.	11/15/2016SE
K132638	Dimension Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional	Siemens Healthcare Diagnostics, Inc.	01/27/2014SE
K133728	Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional	Siemens Healthcare Diagnostics, Inc.	01/24/2014SE
K123586	Easyra Creatinine ReagentCGX · Special	Medica Corporation	05/15/2013SE
K110530	Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…CGX · Abbreviated	Horiba Abx SAS	04/30/2012SE

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K231525	VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional	08/09/2023SE
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K212648	VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional	01/28/2022SE
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Questions and answers

When was Vitros Chemistry Products Crea DT Slides; Vitros Chemistry Products DT Calibrator Kit cleared by the FDA?

Vitros Chemistry Products Crea DT Slides; Vitros Chemistry Products DT Calibrator Kit (K001769) received a 510(k) decision of Substantially Equivalent on June 21, 2000, 9 days after the submission was received.

What is the product code of K001769?

The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.