510(k) Report

Devices descending from K891235

2 later devices reach Primus Model CLC 330 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112015Premier HB9210 HBA1C AnalyzerPrimus Corporation Dba Trinity Biotech20110—
+1K062658Primus A1CARE AssayPrimus Corp.20070—