510(k) Report

Devices descending from K080811

5 later devices reach Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141143Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C…Roche Diagnostics20144—
+2K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH20171—
+2K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo)20161—
+3K242585Cystatin CSENTINEL CH. SpA20250—
+3K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.20180—