510(k) K083896
K083896 is an FDA 510(k) premarket notification submitted by Trinity Biotech for the device "DESTINY MAX COAGULATION ANALYZER". The FDA issued a decision of Substantially Equivalent on July 2, 2009. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Trinity Biotech has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2009
- Date Received
- December 29, 2008
- 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