CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
FDA 510(k) clearance K173202 · decided 2018-05-09
Clearance details
- K-number
- K173202
- Device name
- CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
- Applicant
- Sekisui Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-10-02
- Decision date
- 2018-05-09
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Chuo-Ku, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.