510(k) K193041
K193041 is an FDA 510(k) premarket notification submitted by Accriva Diagnostics, Inc. for the device "Hemochron Signature Elite". The FDA issued a decision of Substantially Equivalent on November 22, 2019. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Accriva Diagnostics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2019
- Date Received
- October 31, 2019
- Clearance Type
- Special
- 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