VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
FDA 510(k) K182063 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK182063
Submission
- Device name
- VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- August 1, 2018
- Decision date
- October 30, 2018
- 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 |
| 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 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System cleared by the FDA?
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (K182063) received a 510(k) decision of Substantially Equivalent on October 30, 2018, 90 days after the submission was received.
What is the product code of K182063?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.