Atellica CH Enzymatic Creatinine_3 (ECre3)
FDA 510(k) K212223 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK212223
Submission
- Device name
- Atellica CH Enzymatic Creatinine_3 (ECre3)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- July 16, 2021
- Decision date
- November 24, 2021
- 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
Other 510(k)s with product code JFY
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|---|---|---|---|
| K252619 | Qscheck UisacrJFY · Traditional | Qstag, Inc. | 02/20/2026SE |
| 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 |
| K183555 | GEM Premier ChemSTATJFY · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
| 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 |
| K132399 | Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…JFY · Traditional | Elitechgroup | 01/03/2014SE |
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Questions and answers
When was Atellica CH Enzymatic Creatinine_3 (ECre3) cleared by the FDA?
Atellica CH Enzymatic Creatinine_3 (ECre3) (K212223) received a 510(k) decision of Substantially Equivalent on November 24, 2021, 131 days after the submission was received.
What is the product code of K212223?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.