510(k) Report

Devices descending from K013359

4 later devices reach LP (a)-Latex Seiken Assay Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122722Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…Roche Diagnostics20121—
+1K082488Diazyme LP (a) AssayGeneral Atomics20093—
+2K241220Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations20250—
+2K131556Diazyme Lipoprotein (a) Calibrator Set, Control SetDiazyme Laboratories20130—