510(k) Report

Devices descending from K945271

2 later devices reach Atac 8000 Random Access Chemistry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121027Diamond Calibrator Low, Diamond Calibrator HighDiamond Diagnostics, Inc.20121—
+2K133751Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsDiamond Diagnostics, Inc.20140—