S-Test Creatinine (Cre)
FDA 510(k) K080073 · Alfa Wassermann, Inc.
510(k) numberK080073
Submission
- Device name
- S-Test Creatinine (Cre)
- Applicant
- Alfa Wassermann, Inc.
West Caldwell, NJ, US - Received
- January 11, 2008
- Decision date
- June 30, 2008
- 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 |
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| K131515 | Ace -Gt Reagent; Ace Lipase Ragent; Ace T4 ReagentKLI · Traditional | 08/14/2013SE |
| K113382 | Ace Alt ReagentCKA · Traditional | 07/19/2012SE |
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| K113435 | Ace Carbon DIOXIDE(CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin…KHS · Traditional | 07/02/2012SE |
| K091413 | S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015…CHH · Traditional | 10/26/2009SE |
| K091544 | S-Test Lactate Dehydrogenase (LD), Model RC 0017CFJ · Traditional | 09/09/2009SE |
| K091333 | S-Test LDL Cholesterol (LDL), Model RC0022MRR · Traditional | 08/03/2009SE |
| K063306 | Ace Hemoglobin A1C Reagent, Model ACI-21, Hemoglobin A1C Calibrators, Model S2-72…LCP · Traditional | 04/17/2007SE |
Questions and answers
When was S-Test Creatinine (Cre) cleared by the FDA?
S-Test Creatinine (Cre) (K080073) received a 510(k) decision of Substantially Equivalent on June 30, 2008, 171 days after the submission was received.
What is the product code of K080073?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.