510(k) Report

Devices descending from K082488

3 later devices reach Diazyme LP (a) Assay through their predicates, nearest generation first.

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