510(k) Report

Devices descending from K013371

3 later devices reach Ubit-IR300 Infrared Spectrometry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052716Rapirun H. Pylori Antibody Detection KitOtsuka Pharmaceutical Co., Ltd.20060—
+1K041148Pocone Infrared SpectrophotometerOtsuka Pharmaceutical Co., Ltd.20040—
+1K014225Breathtek - Ubit Ubt for H. PyloriMeretek Diagnostics, Inc.200201