Creatinine (Enzymatic)
FDA 510(k) K070824 · Thermofisher Scientific OY
510(k) numberK070824
Submission
- Device name
- Creatinine (Enzymatic)
- Applicant
- Thermofisher Scientific OY
Vantaa, FI - Received
- March 26, 2007
- Decision date
- December 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
Other 510(k)s with product code JFY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K110035 | IndikoJJE · Traditional | 06/28/2011SE |
| K073295 | Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional | 05/29/2008SE |
| K073612 | Uric Acid (Aox), Scal, Nortrol, AbtrolJIX · Traditional | 05/23/2008SE |
| K073355 | Calcium, Scal, Nortrol, AbtrolCJY · Traditional | 02/28/2008SE |
| K073191 | Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, AbtrolCJE · Traditional | 02/28/2008SE |
| K071340 | Carbon Dioxide (CO2), Scal, Nortrol and AbtrolKHS · Traditional | 10/05/2007SE |
| K071580 | Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolCIT · Traditional | 10/03/2007SE |
Questions and answers
When was Creatinine (Enzymatic) cleared by the FDA?
Creatinine (Enzymatic) (K070824) received a 510(k) decision of Substantially Equivalent on December 3, 2007, 252 days after the submission was received.
What is the product code of K070824?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.