Multigent Creatinine (Enzymatic) Assay
FDA 510(k) K073634 · SENTINEL CH. SpA
510(k) numberK073634
Submission
- Device name
- Multigent Creatinine (Enzymatic) Assay
- Applicant
- SENTINEL CH. SpA
Milan, IT - Received
- December 26, 2007
- Decision date
- June 19, 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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| 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 Multigent Creatinine (Enzymatic) Assay cleared by the FDA?
Multigent Creatinine (Enzymatic) Assay (K073634) received a 510(k) decision of Substantially Equivalent on June 19, 2008, 176 days after the submission was received.
What is the product code of K073634?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.