Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems Elical 2 Model CALI-0580, Elitech CL
FDA 510(k) K103376 · Seppim S.A.S.
510(k) numberK103376
Submission
- Device name
- Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems Elical 2 Model CALI-0580, Elitech CL
- Applicant
- Seppim S.A.S.
Bothell, WA, US - Received
- November 17, 2010
- Decision date
- November 18, 2011
- 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 |
| 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 |
More from ACON Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102993 | Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLCDT · Traditional | 05/19/2011SE |
| K100547 | Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set…LCP · Traditional | 05/19/2011SE |
| K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsCEO · Traditional | 05/06/2011SE |
| K100525 | Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech…CGA · Traditional | 12/15/2010SE |
| K093883 | Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model ASSL-0250…CIT · Traditional | 09/20/2010SE |
Questions and answers
When was Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems Elical 2 Model CALI-0580, Elitech CL cleared by the FDA?
Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems Elical 2 Model CALI-0580, Elitech CL (K103376) received a 510(k) decision of Substantially Equivalent on November 18, 2011, 366 days after the submission was received.
What is the product code of K103376?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.