510(k) K013596
K013596 is an FDA 510(k) premarket notification submitted by Accumetrics, Inc. for the device "MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)". The FDA issued a decision of Substantially Equivalent on May 16, 2002. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Accumetrics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2002
- Date Received
- October 31, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Automated Platelet Aggregation
- Device Class
- Class II
- Regulation Number
- 864.5700
- Review Panel
- HE
- Submission Type