Cobas C Tina-Quant Cystatin C GEN.2 Assay, C.F.A.S. Cystatin C Calibrator, Cystatin C GEN.2 Control Set
FDA 510(k) K141143 · Roche Diagnostics
510(k) numberK141143
Submission
- Device name
- Cobas C Tina-Quant Cystatin C GEN.2 Assay, C.F.A.S. Cystatin C Calibrator, Cystatin C GEN.2 Control Set
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- May 2, 2014
- Decision date
- July 17, 2014
- 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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| 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 |
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| 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 Cobas C Tina-Quant Cystatin C GEN.2 Assay, C.F.A.S. Cystatin C Calibrator, Cystatin C GEN.2 Control Set cleared by the FDA?
Cobas C Tina-Quant Cystatin C GEN.2 Assay, C.F.A.S. Cystatin C Calibrator, Cystatin C GEN.2 Control Set (K141143) received a 510(k) decision of Substantially Equivalent on July 17, 2014, 76 days after the submission was received.
What is the product code of K141143?
The FDA product code is NDY – Test, Cystatin C, a Class II (moderate risk) device regulated under 21 CFR 862.1225.