510(k) Report

Devices descending from K003501

12 later devices reach N Protein Standard UY Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083906Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N…Siemens Healthcare Diagnostics20090—
+1K080662Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorGenzyme Corporation20080—
+1K063351Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control…Dade Behring, Inc.20070—
+1K041627Cystatin C Immunoparticles, Control Set, CalibratorDako A/S20048—
+2K121588Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3Randox Laboratories, Ltd.20120—
+2K080811Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control…Roche Diagnostics Corp.20085—
+2K063647Cystatin C Antiserum, Calibrator, Control and Control HighThermo Electron OY20070—
+3K141143Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C…Roche Diagnostics20144—
+4K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH20171—
+4K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo)20161—
+5K242585Cystatin CSENTINEL CH. SpA20250—
+5K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.20180—