510(k) K150041
K150041 is an FDA 510(k) premarket notification submitted by Coramed Technologies, LLC for the device "CORA (Coagulation Resonance Analysis) System". The FDA issued a decision of Substantially Equivalent on June 26, 2015. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Coramed Technologies, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2015
- Date Received
- January 9, 2015
- 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