Sekisui Medical Co., Ltd. is one of 79 FDA 510(k) medical device manufacturers from Japan in the dataset, ranked by real submission volume.
Sekisui Medical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
1
Total
1
Cleared
0
Denied
Sekisui Medical Co., Ltd. has 1 FDA 510(k) cleared medical devices. Based in Chuo-Ku, JP.
Historical record: 1 cleared submissions from 2018 to 2018. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Sekisui Medical Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by SEKISUI Diagnostics, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Sekisui Medical Co., Ltd.
1 devices