Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control
FDA 510(k) K110530 · Horiba Abx SAS
510(k) numberK110530
Submission
- Device name
- Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control
- Applicant
- Horiba Abx SAS
Montpellier, FR - Received
- February 24, 2011
- Decision date
- April 30, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| 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 |
| K083809 | CreatinineCGX · Special | Abbott Laboratories | 04/07/2009SE |
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Questions and answers
When was Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control cleared by the FDA?
Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control (K110530) received a 510(k) decision of Substantially Equivalent on April 30, 2012, 431 days after the submission was received.
What is the product code of K110530?
The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.