Panels › Clinical Chemistry › Product code NDY · Class 2
Test, Cystatin C
Regulation 862.1225
0510(k)s in 12 months (22 all time)
0recalls in 12 months (4 all time)
2recalls that name a 510(k)
Top companies in NDY
| Company | 510(k)s | Recalls |
|---|---|---|
| Dade Behring, Inc. | 3 | 0 |
| Diazyme Laboratories | 3 | 0 |
| Gentian AS | 2 | 1 |
| The Binding Site | 2 | 0 |
| Randox Laboratories Ltd. | 0 | 2 |
| Roche Diagnostics | 2 | 0 |
| Siemens Healthcare Diagnostics | 2 | 0 |
| Tosoh Bioscience, Inc. | 1 | 1 |
| Dako A/S | 1 | 0 |
| Genzyme Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 2025 | K242585 | Cystatin C SENTINEL CH. SpA, IT | NDY |
| May 25, 2018 | K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) Siemens Healthcare Diagnostics, Inc. | NDY |
| May 12, 2017 | K171072 | N Latex Cystatin C; N Protein Standard UY Siemens Healthcare Diagnostics Products GmbH, DE | NDY |
| Jul 27, 2016 | K161817 | Tina-quant Cystatin C Gen.2 Roche Diagnostics Operations (Rdo) | NDY |
| Jul 17, 2014 | 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 | NDY |
| Mar 30, 2012 | K111664 | DIAZYME CYSTATIN C POC TEST KIT Diazyme Laboratories | NDY |
| Sep 28, 2010 | K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL Kamiya Biomedical Co. | NDY |
| Sep 14, 2010 | K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 Tosoh Bioscience, Inc. | NDY |
| Apr 8, 2010 | K093680 | DIAZYME CYSTATIN C ASSAY Diazyme Laboratories | NDY |
| Mar 11, 2009 | K083906 | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 Siemens Healthcare Diagnostics | NDY |
| Aug 20, 2008 | K081875 | GENTIAN CYSTATIN C IMMUNOASSAY Gentian AS | NDY |
| Jun 20, 2008 | K080811 | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET Roche Diagnostics Corp. | NDY |
| Jun 6, 2008 | K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER The Binding Site, Ltd. | NDY |
| May 15, 2008 | K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR Genzyme Corporation | NDY |
| Feb 1, 2008 | K072270 | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) Diazyme Laboratories | NDY |
| Jan 24, 2008 | K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER The Binding Site | NDY |
| Nov 6, 2007 | K071388 | GENTIAN CYSTATIN C IMMUNOASSAY Gentian AS | NDY |
| Mar 12, 2007 | K063647 | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH Thermo Electron OY, FI | NDY |
| Jan 22, 2007 | K063351 | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH Dade Behring, Inc. | NDY |
| Sep 3, 2004 | K041627 | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR Dako A/S, DK | NDY |
| Aug 16, 2004 | K041878 | N LATEX CYSTATIN Dade Behring, Inc. | NDY |
| Mar 13, 2001 | K003503 | N LATEX CYSTATIN C Dade Behring, Inc. | NDY |
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