Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator
FDA 510(k) K080662 · Genzyme Corporation
510(k) numberK080662
Submission
- Device name
- Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator
- Applicant
- Genzyme Corporation
Framingham, MA, US - Received
- March 10, 2008
- Decision date
- May 15, 2008
- 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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| K171072 | N Latex Cystatin C; N Protein Standard UYNDY · Traditional | Siemens Healthcare Diagnostics Products GmbH | 05/12/2017SE |
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| 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 |
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Questions and answers
When was Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator cleared by the FDA?
Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator (K080662) received a 510(k) decision of Substantially Equivalent on May 15, 2008, 66 days after the submission was received.
What is the product code of K080662?
The FDA product code is NDY – Test, Cystatin C, a Class II (moderate risk) device regulated under 21 CFR 862.1225.