NDY — Test, Cystatin C Class II
FDA product code NDY covers "Test, Cystatin C", a Class II medical device regulated under 21 CFR 862.1225. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NDY
- Device Class
- Class II
- Regulation Number
- 862.1225
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242585 | sentinel ch | Cystatin C | May 16, 2025 |
| K181082 | siemens healthcare diagnostics | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | May 25, 2018 |
| K171072 | siemens healthcare diagnostics products | N Latex Cystatin C; N Protein Standard UY | May 12, 2017 |
| K161817 | roche diagnostics operations (rdo) | Tina-quant Cystatin C Gen.2 | July 27, 2016 |
| K141143 | roche diagnostics | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTA | July 17, 2014 |
| K111664 | diazyme laboratories | DIAZYME CYSTATIN C POC TEST KIT | March 30, 2012 |
| K093137 | kamiya biomedical | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | September 28, 2010 |
| K093960 | tosoh bioscience | ST AIA-PACK CYSTATIN C, MODEL 025217 | September 14, 2010 |
| K093680 | diazyme laboratories | DIAZYME CYSTATIN C ASSAY | April 8, 2010 |
| K083906 | siemens healthcare diagnostics | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODEL | March 11, 2009 |
| K081875 | gentian | GENTIAN CYSTATIN C IMMUNOASSAY | August 20, 2008 |
| K080811 | roche diagnostics | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C | June 20, 2008 |
| K080384 | binding site | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | June 6, 2008 |
| K080662 | genzyme corporation | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | May 15, 2008 |
| K072270 | diazyme laboratories | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ1 | February 1, 2008 |
| K072166 | binding site | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | January 24, 2008 |
| K071388 | gentian | GENTIAN CYSTATIN C IMMUNOASSAY | November 6, 2007 |
| K063647 | thermo electron | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | March 12, 2007 |
| K063351 | dade behring | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN C | January 22, 2007 |
| K041627 | dako | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR | September 3, 2004 |