510(k) Report

Devices descending from K070734

3 later devices reach Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A, DZ168A-Cal… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay…Diazyme Laboratories20160—
+1K092911Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control Kit, Model…Diazyme Laboratories20101—
+2K111664Diazyme Cystatin C Poc Test KitDiazyme Laboratories20120—