FDA Product Code
FDA Product Code NDY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1225
510(k) Clearances — 22 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242585 | Cystatin C | SENTINEL CH. SpA | 2025-05-16 | Traditional | PDF ↗ |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | 2018-05-25 | Traditional | PDF ↗ |
| K171072 | N Latex Cystatin C; N Protein Standard UY | Siemens Healthcare Diagnostics Products GmbH | 2017-05-12 | Traditional | PDF ↗ |
| K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | 2016-07-27 | Special | PDF ↗ |
| K141143 | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET | Roche Diagnostics | 2014-07-17 | Traditional | PDF ↗ |
| K111664 | DIAZYME CYSTATIN C POC TEST KIT | Diazyme Laboratories | 2012-03-30 | Traditional | PDF ↗ |
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | Kamiya Biomedical Co. | 2010-09-28 | Traditional | PDF ↗ |
| K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 | Tosoh Bioscience, Inc. | 2010-09-14 | Traditional | PDF ↗ |
| K093680 | DIAZYME CYSTATIN C ASSAY | Diazyme Laboratories | 2010-04-08 | Traditional | PDF ↗ |
| K083906 | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 | Siemens Healthcare Diagnostics | 2009-03-11 | Traditional | PDF ↗ |
| K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | 2008-08-20 | Special | PDF ↗ |
| K080811 | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET | Roche Diagnostics Corp. | 2008-06-20 | Traditional | PDF ↗ |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | The Binding Site, Ltd. | 2008-06-06 | Traditional | PDF ↗ |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | Genzyme Corporation | 2008-05-15 | Traditional | PDF ↗ |
| K072270 | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) | Diazyme Laboratories | 2008-02-01 | Traditional | PDF ↗ |
| K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site | 2008-01-24 | Traditional | PDF ↗ |
| K071388 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | 2007-11-06 | Traditional | PDF ↗ |
| K063647 | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | Thermo Electron OY | 2007-03-12 | Traditional | PDF ↗ |
| K063351 | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH | Dade Behring, Inc. | 2007-01-22 | Traditional | PDF ↗ |
| K041627 | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR | Dako A/S | 2004-09-03 | Traditional | PDF ↗ |
| K041878 | N LATEX CYSTATIN | Dade Behring, Inc. | 2004-08-16 | Traditional | PDF ↗ |
| K003503 | N LATEX CYSTATIN C | Dade Behring, Inc. | 2001-03-13 | Traditional | PDF ↗ |
Product code NDY · Class II · Clinical Chemistry. Data: openFDA.