FDA 510(k) Applications for Medical Device Product Code "NDY"
(Test, Cystatin C)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K063351 | DADE BEHRING, INC. | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH | 01/22/2007 |
| K041878 | DADE BEHRING, INC. | N LATEX CYSTATIN | 08/16/2004 |
| K003503 | DADE BEHRING, INC. | N LATEX CYSTATIN C | 03/13/2001 |
| K041627 | DAKO A/S | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR | 09/03/2004 |
| K093680 | DIAZYME LABORATORIES | DIAZYME CYSTATIN C ASSAY | 04/08/2010 |
| K111664 | DIAZYME LABORATORIES | DIAZYME CYSTATIN C POC TEST KIT | 03/30/2012 |
| K072270 | DIAZYME LABORATORIES | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) | 02/01/2008 |
| K071388 | GENTIAN AS | GENTIAN CYSTATIN C IMMUNOASSAY | 11/06/2007 |
| K081875 | GENTIAN AS | GENTIAN CYSTATIN C IMMUNOASSAY | 08/20/2008 |
| K080662 | GENZYME CORPORATION | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | 05/15/2008 |
| K093137 | KAMIYA BIOMEDICAL CO. | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | 09/28/2010 |
| K141143 | Roche Diagnostics | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET | 07/17/2014 |
| K080811 | ROCHE DIAGNOSTICS CORP. | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET | 06/20/2008 |
| K161817 | Roche Diagnostics Operations (RDO) | Tina-quant Cystatin C Gen.2 | 07/27/2016 |
| K083906 | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 | 03/11/2009 |
| K171072 | Siemens Healthcare Diagnostics Products GmbH | N Latex Cystatin C; N Protein Standard UY | 05/12/2017 |
| K181082 | Siemens Healthcare Diagnostics, Inc. | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | 05/25/2018 |
| K072166 | THE BINDING SITE | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | 01/24/2008 |
| K080384 | THE BINDING SITE, LTD. | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | 06/06/2008 |
| K063647 | THERMO ELECTRON OY | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | 03/12/2007 |
| K093960 | Tosoh BioScience, Inc. | ST AIA-PACK CYSTATIN C, MODEL 025217 | 09/14/2010 |
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