510(k) K172333
K172333 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Products GmbH for the device "Sysmex CS-5100". The FDA issued a decision of Substantially Equivalent on October 31, 2017. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Siemens Healthcare Diagnostics Products GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2017
- Date Received
- August 2, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Multipurpose For In Vitro Coagulation Studies
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type