Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2722, 195 7927
FDA 510(k) K071215 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK071215
Submission
- Device name
- Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2722, 195 7927
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- May 2, 2007
- Decision date
- May 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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Questions and answers
When was Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2722, 195 7927 cleared by the FDA?
Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2722, 195 7927 (K071215) received a 510(k) decision of Substantially Equivalent on May 25, 2007, 23 days after the submission was received.
What is the product code of K071215?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.