510(k) Report

Devices descending from K081719

2 later devices reach Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172173DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbH20180—
+1K110393Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin…Ekf-Diagnostic GmbH20110—