Advia Chemistry Enzymatic CREATININE_2
FDA 510(k) K070727 · Siemens Medical Solutions Diagnostics
510(k) numberK070727
Submission
- Device name
- Advia Chemistry Enzymatic CREATININE_2
- Applicant
- Siemens Medical Solutions Diagnostics
Tarrytown, NY, US - Received
- March 15, 2007
- Decision date
- August 3, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFY – Enzymatic Method, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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| K252619 | Qscheck UisacrJFY · Traditional | Qstag, Inc. | 02/20/2026SE |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3)JFY · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/24/2021SE |
| K193649 | Yumizen C1200 Creatinine PAPJFY · Traditional | Horiba Abx SAS | 05/10/2021SE |
| K182384 | ACR LAB Urine Analysis Test SystemJFY · Traditional | Healthy.Io, Ltd. | 07/26/2019SE |
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| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerJFY · Traditional | Yd Diagnostics Corporation | 12/10/2018SE |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…JFY · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/30/2018SE |
| K161527 | Teco Creatinine Enzymatic Reagent KitJFY · Traditional | Teco Diagnostics, Inc. | 07/21/2017SE |
| K152835 | Uritek TC-201 Urine Chemistry Test SystemJFY · Traditional | Teco Diagnostics, Inc. | 03/07/2016SE |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…JFY · Traditional | ACON Laboratories, Inc. | 12/22/2014SE |
More from ACON Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100910 | Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6DHB · Traditional | 05/11/2011SE |
| K091984 | Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6DHB · Traditional | 10/28/2009SE |
| K081895 | Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsLCP · Traditional | 01/08/2009SE |
| K071455 | Advia Centaur Cyclosporine Assay and CalibratorMKW · Traditional | 09/11/2008SE |
| K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265MQM · Traditional | 06/27/2008SE |
| K072658 | Advia Chemistry C-Reactive PROTEIN_2, (CRP_2) and CalibratorsDCN · Traditional | 04/01/2008SE |
| K072794 | Immulite 2500 Om-Ma, Model L5KOPLTK · Special | 11/05/2007SE |
| K071466 | Dca Vantage, Model 5075LCP · Special | 10/09/2007SE |
| K072204 | Advia Chemistry Microalbumin Calibrators, _2 CalibratorsJIX · Abbreviated | 10/05/2007SE |
| K071017 | Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP…NQD · Special | 05/02/2007SE |
Questions and answers
When was Advia Chemistry Enzymatic CREATININE_2 cleared by the FDA?
Advia Chemistry Enzymatic CREATININE_2 (K070727) received a 510(k) decision of Substantially Equivalent on August 3, 2007, 141 days after the submission was received.
What is the product code of K070727?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.