Diazyme Creatinine Liquid Reagents Assay
FDA 510(k) K062105 · Diazyme Laboratories
510(k) numberK062105
Submission
- Device name
- Diazyme Creatinine Liquid Reagents Assay
- Applicant
- Diazyme Laboratories
San Diego, CA, US - Received
- July 24, 2006
- Decision date
- April 23, 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
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| K182384 | ACR LAB Urine Analysis Test SystemJFY · Traditional | Healthy.Io, Ltd. | 07/26/2019SE |
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| 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 Diazyme Creatinine Liquid Reagents Assay cleared by the FDA?
Diazyme Creatinine Liquid Reagents Assay (K062105) received a 510(k) decision of Substantially Equivalent on April 23, 2007, 273 days after the submission was received.
What is the product code of K062105?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.