510(k) Report

Devices descending from K082275

2 later devices reach Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121366Hemocue HBA1C 501Infopia Co, Ltd.20121—
+2K141750Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemInfopia Co, Ltd.20140—