Crea or Creatinine

FDA 510(k) K971908 · Carolina Liquid Chemistries Corp.

Substantially Equivalent

510(k) numberK971908

Submission

Device name
Crea or Creatinine
Applicant
Carolina Liquid Chemistries Corp.
Brea, CA, US
Received
May 23, 1997
Decision date
June 17, 1997
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

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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

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K133519Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries…JJE · Traditional 05/16/2014SE
K132711Carolina Liquid Chemistries HDL Cholesterol ReagentLBS · Traditional 05/08/2014SE
K972073Total Bilirubin ReagentCIG · Traditional 06/24/1997SE
K971907Calcium ReagentCIC · Traditional 06/24/1997SE
K971324Triglycerides, TG, or TrigCDT · Traditional 06/20/1997SE
K971967BunCDQ · Traditional 06/17/1997SE
K971467Synchron CX Systems Glucose Reagent (Glu)CFR · Traditional 06/16/1997SE
K971396CK ReagentCGS · Traditional 05/29/1997SE

Questions and answers

When was Crea or Creatinine cleared by the FDA?

Crea or Creatinine (K971908) received a 510(k) decision of Substantially Equivalent on June 17, 1997, 25 days after the submission was received.

What is the product code of K971908?

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