Creatinkinetic

FDA 510(k) K863079 · J. D. Assoc.

Substantially Equivalent

510(k) numberK863079

Submission

Device name
Creatinkinetic
Applicant
J. D. Assoc.
Montclair, NJ, US
Received
August 12, 1986
Decision date
December 12, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track Nova Biomedical Corporation01/09/2026SE
K251058Tru Kidney Health Test Panel; Tru AnalyzerCGX · Traditional Truvian Health11/26/2025SE
K242685Atellica® CH Creatinine_3 (Crea3)CGX · Traditional Siemens Healthcare Diagnostics, Inc.12/04/2024SE
K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track Nova Biomedical Corporation11/19/2024SE
K210452Creatinine2CGX · Traditional Abbott Ireland Diagnostics Division03/22/2022SE
K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX · Traditional Siemens Healthcare Diagnostics, Inc.11/15/2016SE
K132638Dimension Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional Siemens Healthcare Diagnostics, Inc.01/27/2014SE
K133728Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional Siemens Healthcare Diagnostics, Inc.01/24/2014SE
K123586Easyra Creatinine ReagentCGX · Special Medica Corporation05/15/2013SE
K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…CGX · Abbreviated Horiba Abx SAS04/30/2012SE

More from Horiba Abx SAS

510(k)DeviceDecision
K863103Peg 6,000CHH · Traditional 01/13/1987SE
K863054Ast S.C.E. (Got)CIT · Traditional 01/13/1987SE
K863069MagnesiometerJGJ · Traditional 12/31/1986SE
K863112ProteinmeterJGP · Traditional 12/10/1986SE
K863068LDH S.C.E.CFJ · Traditional 12/10/1986SE
K863053Alt S.C.E. (GPT)CKA · Traditional 12/10/1986SE
K863066TransfermeterJQF · Traditional 12/04/1986SE
K863109FerrofastJIY · Traditional 11/24/1986SE
K863102Glucometer-ECGA · Traditional 11/24/1986SE
K863056Bilirubin TotalCIG · Traditional 11/24/1986SE

Questions and answers

When was Creatinkinetic cleared by the FDA?

Creatinkinetic (K863079) received a 510(k) decision of Substantially Equivalent on December 12, 1986, 122 days after the submission was received.

What is the product code of K863079?

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