N Latex Cystatin C; N Protein Standard UY
FDA 510(k) K171072 · Siemens Healthcare Diagnostics Products GmbH
510(k) numberK171072
Submission
- Device name
- N Latex Cystatin C; N Protein Standard UY
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
Marburg, DE - Received
- April 10, 2017
- Decision date
- May 12, 2017
- 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
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 |
| 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 |
| K093680 | Diazyme Cystatin C AssayNDY · Traditional | Diazyme Laboratories | 04/08/2010SE |
| 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 |
More from Gentian AS
| 510(k) | Device | Decision |
|---|---|---|
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)DHB · Traditional | 09/04/2026SE |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…QLU · Traditional | 10/10/2024SE |
| K233946 | Immulite® 2000 Br-MaMOI · Traditional | 03/13/2024SE |
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)CFN · Special | 12/13/2023SE |
| K213510 | Immulite/Immulite 1000 Om-Ma, Immulite 2000 Om-MaLTK · Traditional | 09/08/2023SE |
| K220728 | vWF AgGGP · Traditional | 06/02/2023SE |
| K212559 | CardioPhase® hsCRPNQD · Special | 12/16/2022SE |
| K212379 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | 03/02/2022SE |
| K201496 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | 10/29/2021SE |
| K193047 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | 07/14/2021SE |
Questions and answers
When was N Latex Cystatin C; N Protein Standard UY cleared by the FDA?
N Latex Cystatin C; N Protein Standard UY (K171072) received a 510(k) decision of Substantially Equivalent on May 12, 2017, 32 days after the submission was received.
What is the product code of K171072?
The FDA product code is NDY – Test, Cystatin C, a Class II (moderate risk) device regulated under 21 CFR 862.1225.