Diazyme Cystatin C Assay
FDA 510(k) K093680 · Diazyme Laboratories
510(k) numberK093680
Submission
- Device name
- Diazyme Cystatin C Assay
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- November 27, 2009
- Decision date
- April 8, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code NDY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242585 | Cystatin CNDY · Traditional | SENTINEL CH. SpA | 05/16/2025SE |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)NDY · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/25/2018SE |
| K171072 | N Latex Cystatin C; N Protein Standard UYNDY · Traditional | Siemens Healthcare Diagnostics Products GmbH | 05/12/2017SE |
| K161817 | Tina-quant Cystatin C Gen.2NDY · Special | Roche Diagnostics Operations (Rdo) | 07/27/2016SE |
| K141143 | Cobas C Tina-Quant Cystatin C GEN.2 Assay, C.F.A.S. Cystatin C Calibrator, Cystatin C…NDY · Traditional | Roche Diagnostics | 07/17/2014SE |
| 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 |
| K083906 | Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N…NDY · Traditional | Siemens Healthcare Diagnostics | 03/11/2009SE |
| K081875 | Gentian Cystatin C ImmunoassayNDY · Special | Gentian AS | 08/20/2008SE |
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Questions and answers
When was Diazyme Cystatin C Assay cleared by the FDA?
Diazyme Cystatin C Assay (K093680) received a 510(k) decision of Substantially Equivalent on April 8, 2010, 132 days after the submission was received.
What is the product code of K093680?
The FDA product code is NDY – Test, Cystatin C, a Class II (moderate risk) device regulated under 21 CFR 862.1225.