CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set— 510(k) K173202
Substantially EquivalentSekisui Medical Co., Ltd.
FDA 510(k) clearance K173202 for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set, Substantially Equivalent on 2018-05-09. Applicant: Sekisui Medical Co., Ltd..
Clearance details
- Applicant
- Sekisui Medical Co., Ltd.
- Product code
- Code JPA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chuo-Ku, JP
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.