Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N 04851534, P/N 10376487
FDA 510(k) K083906 · Siemens Healthcare Diagnostics
510(k) numberK083906
Submission
- Device name
- Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N 04851534, P/N 10376487
- Applicant
- Siemens Healthcare Diagnostics
Tarrytown, NY, US - Received
- December 30, 2008
- Decision date
- March 11, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDY – Test, Cystatin C
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K111664 | Diazyme Cystatin C Poc Test KitNDY · Traditional | Diazyme Laboratories | 03/30/2012SE |
| K093137 | K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional | Kamiya Biomedical Co. | 09/28/2010SE |
| K093960 | ST Aia-Pack Cystatin C, Model 025217NDY · Traditional | Tosoh Bioscience, Inc. | 09/14/2010SE |
| K093680 | Diazyme Cystatin C AssayNDY · Traditional | Diazyme Laboratories | 04/08/2010SE |
| K081875 | Gentian Cystatin C ImmunoassayNDY · Special | Gentian AS | 08/20/2008SE |
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Questions and answers
When was Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N 04851534, P/N 10376487 cleared by the FDA?
Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N 04851534, P/N 10376487 (K083906) received a 510(k) decision of Substantially Equivalent on March 11, 2009, 71 days after the submission was received.
What is the product code of K083906?
The FDA product code is NDY – Test, Cystatin C, a Class II (moderate risk) device regulated under 21 CFR 862.1225.