Creatinine-Po Reagent Kit

FDA 510(k) K943924 · Synermed, Inc.

Substantially Equivalent

510(k) numberK943924

Submission

Device name
Creatinine-Po Reagent Kit
Applicant
Synermed, Inc.
Quebec, Canada, CA
Received
August 12, 1994
Decision date
September 20, 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
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)DeviceApplicantDecision
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
K973109Synermed Near-Infrared Direct Bilirubin Reagent KitCIG · Traditional 09/25/1997SE
K972716Synermed Total Bilirubin Reagent KitCIG · Traditional 08/07/1997SE
K971491Synermed Ir 200 Chemistry AnalyzerJJF · Traditional 06/26/1997SE
K962479Synermed Ise ReagentsCGZ · Traditional 03/03/1997SE
K963939Synermed Direct Bilirubin Reagent KitCIG · Traditional 12/18/1996SE
K960793Synermed Enzymatic CO2 Reagent KitKHS · Traditional 03/11/1996SE
K953395Synermed Calcium Reagent KitCJY · Traditional 08/31/1995SE
K952179Synermed Ise ReagentsJGS · Traditional 06/20/1995SE
K941091Synermed Amylase Reagent KitJFJ · Traditional 05/03/1994SE
K941400Synermed Ise ReagentsJGS · Traditional 04/26/1994SE

Questions and answers

When was Creatinine-Po Reagent Kit cleared by the FDA?

Creatinine-Po Reagent Kit (K943924) received a 510(k) decision of Substantially Equivalent on September 20, 1994, 39 days after the submission was received.

What is the product code of K943924?

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